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id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2026-P-5454-0009 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 7 - Smarr, M. M., et al. (2016). Urinary paracetamol and time-to-pregnancy. Human Reproduction, 31(9), 2119-2127. URL: https://pubmed.ncbi.nlm.nih.gov/27412248/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:39Z   0 0 09000064b92d5011
FDA-2026-P-5454-0014 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 12 - de Araújo-Ramos, A. T., et al. (2026). Differential disruption of gonadal development by DEHP and paracetamol in male and female Wistar rats. Reproductive Toxicology, 141, 109183. URL: https://doi.org/10.1016/j.reprotox.2026.109183 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:56Z   0 0 09000064b92d5031
FDA-2026-P-5454-0015 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 13 - Laursen, T. Q., et al. (2024). Maternal intake of paracetamol during pregnancy and biomarkers of male fecundity in young adult sons. Reproductive Toxicology, 127, 108626. URL: https://doi.org/10.1016/j.reprotox.2024.108626 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:00Z   0 0 09000064b92d5032
FDA-2026-P-5454-0011 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 9 - Carlsen, L. N., et al. (2024). Overuse of analgesics can affect the fertility biomarker Anti-Müllerian Hormone in females. A translational study. Cephalalgia, 44(11). URL: https://doi.org/10.1177/03331024241290530 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:46Z   0 0 09000064b92d5013
FDA-2026-P-5454-0004 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 2 - Fisher, B. G., et al. (2016). Prenatal paracetamol exposure is associated with shorter anogenital distance in male infants. Human Reproduction, 31(11), 2642-2650. URL: https://pubmed.ncbi.nlm.nih.gov/27609981/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:41:58Z   0 0 09000064b92d500c
FDA-2026-P-5454-0013 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 11 - Wu, T., et al. (2024). Prenatal acetaminophen exposure and the developing ovary: time, dose, and course consequences for fetal mice. Food and Chemical Toxicology, 189, 114679. URL: https://doi.org/10.1016/j.fct.2024.114679 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:53Z   0 0 09000064b92d5030
FDA-2026-P-5578-0004 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. FDA-2026-P-5578 Attachment 2 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:18:09Z   0 0 09000064b92d70f1
FDA-2026-P-5578-0005 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. FDA-2026-P-5578 Attachment 3 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:18:14Z   0 0 09000064b92d70f2
FDA-2026-P-5454-0017 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 15 - Lee, C. Y., et al. (2023). Effects of acetaminophen on reproductive activities in male golden hamsters. Development & Reproduction, 27(1), 25-37. URL: https://doi.org/10.12717/DR.2023.27.1.25 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:26Z   0 0 09000064b92d5034
FDA-2026-P-5611-0003 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 attachment-1-orange-book-page Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:37:59Z   0 0 09000064b92d874f
FDA-2026-P-5454-0021 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 19 - Eletri, L., et al. (2026). Association between in utero exposure to acetaminophen and external genital tract malformations in boys and girls: a systematic review and meta-analysis. Human Reproduction, 41(3), 427-442. URL: https://doi.org/10.1093/humrep/deaf253 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:53Z   0 0 09000064b92d5038
FDA-2026-P-5454-0003 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 1 - Ernstsen, C., et al. (2026). Prenatal paracetamol modulates sexually dimorphic behaviour and steroidogenesis in adult male and female mice. Reproduction, 171(2). URL: https://doi.org/10.1093/reprod/xaag007 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:41:54Z   0 0 09000064b92d500b
FDA-2026-P-5454-0006 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 4 - Guzmán-Montemayor, A. J., et al. (2026). Prenatal, but not neonatal, paracetamol exposure disrupts neuroendocrine regulation of stress and emotional behavior in adult male rats. Physiology & Behavior, 308, 115261. URL: https://doi.org/10.1016/j.physbeh.2026.115261 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:16Z   0 0 09000064b92d500e
FDA-2026-P-5454-0007 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 5 - Górawski, F., et al. (2026). Sex-dependent effects of early-life paracetamol exposure on behavior and monoamines in the rat central nervous system. Chemico-Biological Interactions, 427, 111937. URL: https://doi.org/10.1016/j.cbi.2026.111937 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:31Z   0 0 09000064b92d500f
FDA-2026-P-5611-0004 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 attachment-2-rld-labeling Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:38:03Z   0 0 09000064b92d8750
FDA-2026-P-5611-0005 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 attachment-3-test-product-draft-labeling Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:38:07Z   0 0 09000064b92d8751
FDA-2026-P-5454-0005 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 3 - Lind, D. V., et al. (2017). Maternal use of mild analgesics during pregnancy associated with reduced anogenital distance in sons. Human Reproduction, 32(1), 149-155. URL: https://pubmed.ncbi.nlm.nih.gov/27852690/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:12Z   0 0 09000064b92d500d
FDA-2026-P-5454-0018 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 16 - Xu, M., et al. (2024). Association of acetaminophen use with perinatal outcomes among pregnant women: a retrospective cohort study with propensity score matching. BMC Pregnancy and Childbirth, 24, 268. URL: https://doi.org/10.1186/s12884-024-06480-5 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:29Z   0 0 09000064b92d5035
FDA-2026-P-5454-0023 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 21 - OFIRMEV (acetaminophen) Injection Package Insert. (2018). Mallinckrodt Hospital Products Inc. Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:44:02Z   0 0 09000064b92d503a
FDA-2026-P-5454-0020 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 18 - Rehfeld, A., et al. (2022). Human sperm cells can form paracetamol metabolite AM404 that directly interferes with sperm calcium signalling and function through a CatSper-dependent mechanism. Human Reproduction, 37(5), 922-935. URL: https://doi.org/10.1093/humrep/deac042 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:48Z   0 0 09000064b92d5037
FDA-2026-P-5454-0022 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 20 - Kougias, D. G., et al. (2025). A quantitative weight-of-evidence review of preclinical studies examining the potential developmental and reproductive toxicity of acetaminophen. Critical Reviews in Toxicology, 55(2), 179-226. URL: https://doi.org/10.1080/10408444.2024.2446471 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:58Z   0 0 09000064b92d5039
FDA-2026-P-5454-0010 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 8 - Nielsen, B. S., et al. (2025). Paracetamol disrupts early embryogenesis by cell cycle inhibition. Human Reproduction, 40(10), 1860-1876. URL: https://doi.org/10.1093/humrep/deaf116 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:42Z   0 0 09000064b92d5012
FDA-2026-P-5454-0019 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 17 - Zafeiri, A., et al. (2022). Maternal over-the-counter analgesics use during pregnancy and adverse perinatal outcomes: cohort study of 151,141 singleton pregnancies. BMJ Open, 12(5), e048092. URL: https://doi.org/10.1136/bmjopen-2020-048092 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:32Z   0 0 09000064b92d5036
FDA-2026-P-5454-0008 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 References 6 - Lecante, L. L., et al. (2022). Acetaminophen interferes with the first trimester human fetal ovary development in an ex vivo model. Journal of Clinical Endocrinology & Metabolism, 107(6), 1647-1661. URL: https://pubmed.ncbi.nlm.nih.gov/35147701/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:35Z   0 0 09000064b92d5010
FDA-2026-P-5454-0012 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 10 - Liu, F., et al. (2024). Maternal administration of acetaminophen affects meiosis through its metabolite NAPQI targeting SIRT7 in fetal oocytes. Antioxidants & Redox Signaling, 41, 93-109. URL: https://doi.org/10.1089/ars.2023.0270 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:50Z   0 0 09000064b92d502f
FDA-2026-P-5454-0016 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Reference 14 - Andreasen, S. M., et al. (2025). Maternal urinary paracetamol concentrations and self-reported paracetamol use in mid-gestation: association to reduced anogenital distance in offspring from infancy to 9 years. Reproductive Toxicology, 135, 108946. URL: https://pubmed.ncbi.nlm.nih.gov/40374128/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:22Z   0 0 09000064b92d5033
FDA-2026-P-5578-0003 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. FDA-2026-P-5578 Attachment 1 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:18:06Z   0 0 09000064b92d70f0
FDA-2026-N-0005-0003 FDA Public Seminar FDA-2026-N-0005 Reference 2 - Kalaria SN, TR Farchione, R Uppoor, M Mehta, Y Wang, and H Zhu, 2021, Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder, Journal of Clinical Pharmacology, 61: S117–S124, doi: 10.1002/jcph.1836. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:07:12Z   0 0 09000064b92d59a0
FDA-2026-N-2526-0005 FDA Butylated hydroxytoluene (BHT); Request for Information FDA-2026-N-2526 Reference 3 - Codex General Standard for Food Additives 2025 Food Categories Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T17:52:48Z   0 0 09000064b92d40e8
FDA-2026-N-2526-0002 FDA Butylated hydroxytoluene (BHT); Request for Information FDA-2026-N-2526 Reference List Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T17:52:37Z   0 0 09000064b92d40e5
FDA-2026-N-2526-0004 FDA Butylated hydroxytoluene (BHT); Request for Information FDA-2026-N-2526 Reference 2 - What We Eat in America Food Categories, available at https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/dmr-food-categories/. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T17:52:45Z   0 0 09000064b92d40e7
FDA-2026-P-5453-0004 FDA Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption FDA-2026-P-5453 Attachment 2 - de la Plaza Llamas et al. - Laparoscopic Removal of a Displaced Vertical Gastric Clip Causing Gastric Outlet Obstruction Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:05:03Z   0 0 09000064b92d58f6
FDA-2026-N-0005-0004 FDA Public Seminar FDA-2026-N-0005 Reference 3 - Kalaria SN, TR Farchione, MV Mathis, M Gopalakrishnan, I Younis, R Uppoor, M Mehta, Y Wang, and H Zhu, 2020, Assessment of Similarity in Antipsychotic Exposure-Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia, Journal of Clinical Pharmacology, 60(7): 848–859, doi: 10.1002/jcph.1580. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:07:15Z   0 0 09000064b92d59a1
FDA-2026-N-2526-0003 FDA Butylated hydroxytoluene (BHT); Request for Information FDA-2026-N-2526 Reference 1 - Citizen Petition from Roger D. Middlekauff, dated December 23, 1986, available at regulations.gov in Docket No. FDA-2026-N-2526. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T17:52:41Z   0 0 09000064b92d40e6
FDA-2026-P-5453-0003 FDA Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption FDA-2026-P-5453 Attachment 1 - Bonaldi et al. - 2024 - BariClip Outcomes and Complications from a Single-Center Experience Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:04:57Z   0 0 09000064b92d58f5
FDA-2026-N-4126-0003 FDA Azodicarbonamide (ADA); Request for Information FDA-2026-N-4126 Reference 2 - Codex General Standard for Food Additives, available at https://www.fao.org/gsfaonline/foods/index.html. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:35:23Z   0 0 09000064b92d66b5
FDA-2026-P-5453-0005 FDA Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption FDA-2026-P-5453 Attachment 3 - Jacobs et al. - 2017 - A Vertically Placed Clip for Weight Loss: a 39-Month Pilot Study Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:05:09Z   0 0 09000064b92d5d02
FDA-2026-N-0005-0002 FDA Public Seminar FDA-2026-N-0005 Reference 1 - Chen J, J Florian, W Carter, RD Fleischer, TS Hammerstrom, PR Jadhav, W Zeng, J Murray, and D Birnkrant, 2013, Earlier Sustained Virologic Response End Points for Regulatory Approval and Dose Selection of Hepatitis C Therapies, Gastroenterology, 144(7):1450–1455.e2, epub ahead of print March 5, 2013, doi: 10.1053/j.gastro.2013.02.039. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:07:08Z   0 0 09000064b92d599f
FDA-2026-N-4126-0002 FDA Azodicarbonamide (ADA); Request for Information FDA-2026-N-4126 Reference 1 - What We Eat in America Food Categories, available at https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/dmr-food-categories/. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:35:19Z   0 0 09000064b92d66b4
FDA-2026-D-5083-0003 FDA Enforcement Policies for Certain Electronic Nicotine Delivery Systems (ENDS) Marketed Without Premarket Authorization; Guidance for Industry; Availability FDA-2026-D-5083 FINAL Enforcement Priorities For ENDS Guidance Withdrawal Supporting & Related Material Background Material 2026-05-12T04:00:00Z 2026 5     2026-05-13T00:47:28Z   0 0 09000064b92d3127
FDA-2026-P-5116-0007 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Appendix V - Reinhardt L, et al. Systematic mapping of fluoroquinolone off-target effects in human cells reveals mitochondrial and metabolic pathway interactions. Angew Chem Int Ed. 2025. Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T23:22:24Z   0 0 09000064b92c88ff
FDA-2026-P-5194-0006 FDA Requests that the FDA declare that the drug product Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-5194 Attachment 4 Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T21:17:25Z   0 0 09000064b92cfc11
FDA-2026-P-5116-0005 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Appendix III - Hangas A, Aasumets K, Kekäläinen NJ, Paloheinä M, Pohjoismäki JLO, Gerhold JM. Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2. Pharmacol Res. 2018;132:101–110. Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T23:22:14Z   0 0 09000064b92c88fd
FDA-2026-N-4268-0002 FDA Medical Devices; Exemptions from Premarket Notification: Certain Class II Devices; Request for Comments FDA-2026-N-4268 Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-12T01:17:00Z   0 0 09000064b92d0a0e
FDA-2026-P-5194-0004 FDA Requests that the FDA declare that the drug product Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-5194 Attachment 2 Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T21:17:18Z   0 0 09000064b92cfc0f
FDA-2026-P-5116-0003 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Appendix I - FDA 2013 Safety Communication (peripheral neuropathy warning) Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T23:22:04Z   0 0 09000064b92c88fb
FDA-2026-P-5116-0004 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Appendix II - FDA 2015 Joint Advisory Committee Materials (FQAD / multisystem discussion) Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T23:22:09Z   0 0 09000064b92c88fc
FDA-2026-P-5194-0003 FDA Requests that the FDA declare that the drug product Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-5194 Attachment 1 Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T21:17:14Z   0 0 09000064b92cfc0e
FDA-2026-P-5194-0005 FDA Requests that the FDA declare that the drug product Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-5194 Attachment 3 Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T21:17:21Z   0 0 09000064b92cfc10
FDA-2026-P-5116-0006 FDA Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics FDA-2026-P-5116 Appendix IV - Kalghatgi S, Spina CS, Costello JC, et al. Bactericidal antibiotics induce mitochondrial dysfunction and oxidative damage in mammalian cells. Sci Transl Med. 2013;5(192):192ra85. Supporting & Related Material Background Material 2026-05-11T04:00:00Z 2026 5     2026-05-11T23:22:19Z   0 0 09000064b92c88fe
FDA-2026-P-5122-0002 FDA Requests that the FDA declare that an ANDA may be submitted for, Prazosin Hydrochloride Capsules, USP 3 mg and 4 mg, two strength’s that differ from the currently approved RLD, MINIPRESS (Prazosin Hydrochloride) capsules from PFIZER LABORATORIES DIV PFIZER INC., which FDA approved in 1 mg, 2 mg, and 5 mg strengths prior to Jan 1, 1982 under NDA #017442. FDA-2026-P-5122 Attachment 2 Supporting & Related Material Background Material 2026-05-08T04:00:00Z 2026 5     2026-05-09T00:33:13Z   0 0 09000064b92c91bb
FDA-2026-P-5122-0001 FDA Requests that the FDA declare that an ANDA may be submitted for, Prazosin Hydrochloride Capsules, USP 3 mg and 4 mg, two strength’s that differ from the currently approved RLD, MINIPRESS (Prazosin Hydrochloride) capsules from PFIZER LABORATORIES DIV PFIZER INC., which FDA approved in 1 mg, 2 mg, and 5 mg strengths prior to Jan 1, 1982 under NDA #017442. FDA-2026-P-5122 Attachment 1 Supporting & Related Material Background Material 2026-05-08T04:00:00Z 2026 5     2026-05-09T00:33:10Z   0 0 09000064b92c91ba
FDA-2026-P-5122-0003 FDA Requests that the FDA declare that an ANDA may be submitted for, Prazosin Hydrochloride Capsules, USP 3 mg and 4 mg, two strength’s that differ from the currently approved RLD, MINIPRESS (Prazosin Hydrochloride) capsules from PFIZER LABORATORIES DIV PFIZER INC., which FDA approved in 1 mg, 2 mg, and 5 mg strengths prior to Jan 1, 1982 under NDA #017442. FDA-2026-P-5122 Attachment 3 Supporting & Related Material Background Material 2026-05-08T04:00:00Z 2026 5     2026-05-09T00:33:16Z   0 0 09000064b92c93af
FDA-2026-P-5123-0003 FDA Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application for Gabapentin Capsules, 150 mg. FDA-2026-P-5123 Attachment 1 Supporting & Related Material Background Material 2026-05-08T04:00:00Z 2026 5     2026-05-09T00:23:09Z   0 0 09000064b92c8037
FDA-2026-P-5123-0004 FDA Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application for Gabapentin Capsules, 150 mg. FDA-2026-P-5123 Attachment 2 Supporting & Related Material Background Material 2026-05-08T04:00:00Z 2026 5     2026-05-09T00:23:13Z   0 0 09000064b92ca501
FDA-2026-P-5017-0003 FDA Request that the FDA determine whether the Reference Listed Drug (RLD) VELTASSA (PATIROMER SORBITEX CALCIUM) Oral Powder, Eq 25.2 gm Base/Packet; under New Drug Application (NDA) 205739 held by VIFOR PHARMA INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons FDA-2026-P-5017 Attachment 1 Supporting & Related Material Background Material 2026-05-07T04:00:00Z 2026 5     2026-05-07T23:44:54Z   0 0 09000064b92c7c24
FDA-2026-P-4918-0006 FDA Requests that the FDA declare that the proposed drug product, Desloratadine Tablets, 2.5 mg, is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is CLARINEX® (desloratadine) RediTabs®, 2.5 mg by Organon LLC, NDA #021312 FDA-2026-P-4918 Attachment 4 - Federal Register Notice August 9, 2022 Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:12:44Z   0 0 09000064b92c528c
FDA-2026-P-4885-0005 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 2 - 21 USC 353 prescription drugs Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:43:59Z   0 0 09000064b92c40c7
FDA-2026-P-4885-0014 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 11 - CDC national diabetes statistics report webpage copy Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:28Z   0 0 09000064b92c550e
FDA-2026-P-4885-0015 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 12 - CDC CKD factsheet 2026 Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:31Z   0 0 09000064b92c550f
FDA-2026-P-4885-0006 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 3 - 21 CFR 310 200 prescription exemption Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:02Z   0 0 09000064b92c5506
FDA-2026-P-4885-0007 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 4 - FDA Rx to OTC switches webpage copy Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:04Z   0 0 09000064b92c5507
FDA-2026-P-4885-0003 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Appendix A Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:43:52Z   0 0 09000064b92c75db
FDA-2026-P-4885-0017 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 14 - CDC chronic disease costs fast facts webpage copy Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:38Z   0 0 09000064b92c5511
FDA-2026-P-4885-0004 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 1 - 21 CFR 10 30 citizen petition Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:43:55Z   0 0 09000064b92c40c6
FDA-2026-P-4885-0012 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 9 - CDC high blood pressure interventions webpage copy Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:22Z   0 0 09000064b92c550c
FDA-2026-P-4885-0010 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 7 - DEA controlled substances alpha order Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:16Z   0 0 09000064b92c550a
FDA-2026-P-4885-0011 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 8 - AMN 2025 physician appointment wait times Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:19Z   0 0 09000064b92c550b
FDA-2026-P-4918-0005 FDA Requests that the FDA declare that the proposed drug product, Desloratadine Tablets, 2.5 mg, is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is CLARINEX® (desloratadine) RediTabs®, 2.5 mg by Organon LLC, NDA #021312 FDA-2026-P-4918 Attachment 3 - Draft Proposed Package Insert for Desloratadine Tablets Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:12:42Z   0 0 09000064b92c528b
FDA-2026-P-4885-0008 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 5 - FDA prescription to nonprescription switch list webpage copy Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:08Z   0 0 09000064b92c5508
FDA-2026-P-4885-0013 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 10 - NCHS data brief 511 hypertension 2024 Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:26Z   0 0 09000064b92c550d
FDA-2026-P-4885-0018 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 15 - Farley 2010 preventive services citation copy Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:42Z   0 0 09000064b92c5512
FDA-2026-P-4918-0003 FDA Requests that the FDA declare that the proposed drug product, Desloratadine Tablets, 2.5 mg, is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is CLARINEX® (desloratadine) RediTabs®, 2.5 mg by Organon LLC, NDA #021312 FDA-2026-P-4918 Attachment 1 - Current Orange Book listing for RLD Clarinex NDA 021312 Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:12:38Z   0 0 09000064b92c5288
FDA-2026-P-4885-0019 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 16 - 21 CFR 25 30 categorical exclusion Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:45Z   0 0 09000064b92c5513
FDA-2026-P-4885-0009 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 6 - FDA ACNU final rule 2024 Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:11Z   0 0 09000064b92c5509
FDA-2026-P-4918-0004 FDA Requests that the FDA declare that the proposed drug product, Desloratadine Tablets, 2.5 mg, is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is CLARINEX® (desloratadine) RediTabs®, 2.5 mg by Organon LLC, NDA #021312 FDA-2026-P-4918 Attachment 2 - Current Package Insert Clarinex NDA 021312 Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:12:40Z   0 0 09000064b92c528a
FDA-2026-P-4885-0016 FDA Requests that the FDA initiate rulemaking and related administrative action to place non-abused human drugs over the counter. "Non-abused" means human drugs that are not scheduled under the Controlled Substances Act and are not currently marketed as controlled substances. FDA-2026-P-4885 Reference 13 - CDC high cholesterol facts webpage copy Supporting & Related Material Background Material 2026-05-06T04:00:00Z 2026 5     2026-05-06T22:44:35Z   0 0 09000064b92c5510
FDA-2026-P-4853-0005 FDA Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets, USP 200 mg strength FDA-2026-P-4853 Attachment 3 - US Agent Appointment Letter Annexure Supporting & Related Material Background Material 2026-05-05T04:00:00Z 2026 5     2026-05-05T23:48:22Z   0 0 09000064b92c3c00
FDA-2026-P-4854-0003 FDA Requests that the FDA add Pharmacokinetic Parameters for estradiol be added to Table 2 in Section 12.3 of the full prescribing information inser for all doses of Premarin. FDA-2026-P-4854 National Library of Medicine estrone content Supporting & Related Material Background Material 2026-05-05T04:00:00Z 2026 5     2026-05-06T01:06:29Z   0 0 09000064b92c39fd
FDA-2026-P-4853-0003 FDA Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets, USP 200 mg strength FDA-2026-P-4853 Attachment 1 - Orange book Database Annexure Supporting & Related Material Background Material 2026-05-05T04:00:00Z 2026 5     2026-05-05T23:48:18Z   0 0 09000064b92c3bdc
FDA-2026-P-4854-0004 FDA Requests that the FDA add Pharmacokinetic Parameters for estradiol be added to Table 2 in Section 12.3 of the full prescribing information inser for all doses of Premarin. FDA-2026-P-4854 National Library of Medicine Medline Plus Hypogonadism definition Supporting & Related Material Background Material 2026-05-05T04:00:00Z 2026 5     2026-05-06T01:06:32Z   0 0 09000064b92c39fe
FDA-2026-P-4853-0004 FDA Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets, USP 200 mg strength FDA-2026-P-4853 Attachment 2 - Package Insert Annexure Supporting & Related Material Background Material 2026-05-05T04:00:00Z 2026 5     2026-05-05T23:48:20Z   0 0 09000064b92c3bdf
FDA-2026-P-4854-0005 FDA Requests that the FDA add Pharmacokinetic Parameters for estradiol be added to Table 2 in Section 12.3 of the full prescribing information inser for all doses of Premarin. FDA-2026-P-4854 Premarin tablets full prescribing information Sections 5 - 12 Supporting & Related Material Background Material 2026-05-05T04:00:00Z 2026 5     2026-05-06T01:06:38Z   0 0 09000064b92c39ff
FDA-2023-N-0437-34796 FDA Filing of Color Additive Petition from Center for Science in the Public Interest, et al.; Request to Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs. FDA-2023-N-0437 Reference 1 - CAC Red 3 Memo Signed 10 30 19 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T22:13:20Z   0 0 09000064b92ba6d3
FDA-2023-N-0437-34799 FDA Filing of Color Additive Petition from Center for Science in the Public Interest, et al.; Request to Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs. FDA-2023-N-0437 Reference 5 - CAP 3C0323_T_memo_final Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T22:14:03Z   0 0 09000064b92ba6d6
FDA-2026-P-4800-0008 FDA Requests that the FDA declare that the proposed drug product, Apixaban orally di sintegrating tablets 2.5 mg and 5 mg is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is ELIQUIS® (apixaban) Tablets, 2.5 mg and 5 mg, by Bristol-Myers Squibb, NDA #202155 FDA-2026-P-4800 Attachment 6 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T21:21:07Z   0 0 09000064b92c17f5
FDA-2026-P-4800-0005 FDA Requests that the FDA declare that the proposed drug product, Apixaban orally di sintegrating tablets 2.5 mg and 5 mg is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is ELIQUIS® (apixaban) Tablets, 2.5 mg and 5 mg, by Bristol-Myers Squibb, NDA #202155 FDA-2026-P-4800 Attachment 3 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T21:21:01Z   0 0 09000064b92c17d6
FDA-2026-P-4800-0007 FDA Requests that the FDA declare that the proposed drug product, Apixaban orally di sintegrating tablets 2.5 mg and 5 mg is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is ELIQUIS® (apixaban) Tablets, 2.5 mg and 5 mg, by Bristol-Myers Squibb, NDA #202155 FDA-2026-P-4800 Attachment 5 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T21:21:05Z   0 0 09000064b92c17f4
FDA-2026-P-4800-0009 FDA Requests that the FDA declare that the proposed drug product, Apixaban orally di sintegrating tablets 2.5 mg and 5 mg is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is ELIQUIS® (apixaban) Tablets, 2.5 mg and 5 mg, by Bristol-Myers Squibb, NDA #202155 FDA-2026-P-4800 Reference 1 - Blaszczyk 2023 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T21:21:10Z   0 0 09000064b92c17f6
FDA-2026-P-4800-0010 FDA Requests that the FDA declare that the proposed drug product, Apixaban orally di sintegrating tablets 2.5 mg and 5 mg is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is ELIQUIS® (apixaban) Tablets, 2.5 mg and 5 mg, by Bristol-Myers Squibb, NDA #202155 FDA-2026-P-4800 Reference 2 - Ozaki 2020 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T21:21:12Z   0 0 09000064b92c17f7
FDA-2026-P-4800-0003 FDA Requests that the FDA declare that the proposed drug product, Apixaban orally di sintegrating tablets 2.5 mg and 5 mg is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is ELIQUIS® (apixaban) Tablets, 2.5 mg and 5 mg, by Bristol-Myers Squibb, NDA #202155 FDA-2026-P-4800 Attachment 1 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T21:20:56Z   0 0 09000064b92c17d2
FDA-2026-P-4800-0004 FDA Requests that the FDA declare that the proposed drug product, Apixaban orally di sintegrating tablets 2.5 mg and 5 mg is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is ELIQUIS® (apixaban) Tablets, 2.5 mg and 5 mg, by Bristol-Myers Squibb, NDA #202155 FDA-2026-P-4800 Attachment 2 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T21:20:58Z   0 0 09000064b92c17d5
FDA-2023-N-0437-34798 FDA Filing of Color Additive Petition from Center for Science in the Public Interest, et al.; Request to Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs. FDA-2023-N-0437 Reference 4 - Toxicology Update Memorandum_FDCRed3_OCCcleared_42226 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T22:13:48Z   0 0 09000064b92ba6d5
FDA-2023-N-0437-34797 FDA Filing of Color Additive Petition from Center for Science in the Public Interest, et al.; Request to Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs. FDA-2023-N-0437 Reference 2 - Cancer Evaluation Criteria_National Toxicology Program Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T22:13:35Z   0 0 09000064b92ba6d4
FDA-2023-N-0437-34795 FDA Filing of Color Additive Petition from Center for Science in the Public Interest, et al.; Request to Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs. FDA-2023-N-0437 References List for FDA-2023-N-0437 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T22:13:06Z   0 0 09000064b92ba6d7
FDA-2026-P-4800-0006 FDA Requests that the FDA declare that the proposed drug product, Apixaban orally di sintegrating tablets 2.5 mg and 5 mg is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is ELIQUIS® (apixaban) Tablets, 2.5 mg and 5 mg, by Bristol-Myers Squibb, NDA #202155 FDA-2026-P-4800 Attachment 4 Supporting & Related Material Background Material 2026-05-04T04:00:00Z 2026 5     2026-05-04T21:21:03Z   0 0 09000064b92c17f3
FDA-2026-P-4762-0034 FDA Requests that the FDA Require ANDA 220582 to be supported with in vivo bioequivalence data from a study involving the product for which approval is being sought under the ANDA; Require ANDA 220582 and other ANDAs that reference BELBUCA to include data and information justifying the entire pH range in the product specifications to ensure that intentional changes to pH compared to BELBUCA. FDA-2026-P-4762 Tab 32 - Bunavail Summary Review Excerpt Supporting & Related Material Background Material 2026-05-01T04:00:00Z 2026 5     2026-05-01T22:30:21Z   0 0 09000064b92bd207
FDA-2026-P-4762-0017 FDA Requests that the FDA Require ANDA 220582 to be supported with in vivo bioequivalence data from a study involving the product for which approval is being sought under the ANDA; Require ANDA 220582 and other ANDAs that reference BELBUCA to include data and information justifying the entire pH range in the product specifications to ensure that intentional changes to pH compared to BELBUCA. FDA-2026-P-4762 Tab 15 - Chemo Joint Letter 2026 Public Version Supporting & Related Material Background Material 2026-05-01T04:00:00Z 2026 5     2026-05-01T22:29:03Z   0 0 09000064b92bd1f6
FDA-2026-P-4762-0006 FDA Requests that the FDA Require ANDA 220582 to be supported with in vivo bioequivalence data from a study involving the product for which approval is being sought under the ANDA; Require ANDA 220582 and other ANDAs that reference BELBUCA to include data and information justifying the entire pH range in the product specifications to ensure that intentional changes to pH compared to BELBUCA. FDA-2026-P-4762 Tab 4 - Arius Two v Alvogen 2022 WL 17828352 Supporting & Related Material Background Material 2026-05-01T04:00:00Z 2026 5     2026-05-01T22:28:18Z   0 0 09000064b92bd1e7
FDA-2026-P-4762-0013 FDA Requests that the FDA Require ANDA 220582 to be supported with in vivo bioequivalence data from a study involving the product for which approval is being sought under the ANDA; Require ANDA 220582 and other ANDAs that reference BELBUCA to include data and information justifying the entire pH range in the product specifications to ensure that intentional changes to pH compared to BELBUCA. FDA-2026-P-4762 Tab 11 - Declaration of Alvogen Expert Dr Michniak Kohn Supporting & Related Material Background Material 2026-05-01T04:00:00Z 2026 5     2026-05-01T22:28:45Z   0 0 09000064b92bd1ee

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