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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

5 rows where docket_id = "FDA-2026-P-5578" sorted by posted_date descending

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Suggested facets: subtype, open_for_comment, posted_date (date), comment_start_date (date), last_modified (date)

document_type 2

  • Supporting & Related Material 3
  • Other 2

posted_year 1

  • 2026 5

agency_id 1

  • FDA 5
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-5578-0001 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 Suitability Petition from Appco Pharma LLC Other Petition(s) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:17:53Z   1 0 09000064b92d8f5b
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-5578-0002 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 Acknowledgement Letter from FDA DMB to Appco Pharma LLC Other Acknowledgement Letter/Receipt 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:17:57Z   0 0 09000064b92d8f63
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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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