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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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