home / openregs

documents

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

10 rows where docket_id = "FDA-2026-P-4800" sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

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

document_type 2

  • Supporting & Related Material 8
  • Other 2

posted_year 1

  • 2026 10

agency_id 1

  • FDA 10
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-4800-0001 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 Suitability Petition from Unison Pharmaceuticals Pvt. Ltd. Other Petition(s) 2026-05-04T04:00:00Z 2026 5 2026-05-04T04:00:00Z   2026-05-04T21:17:59Z   1 0 09000064b92bd70c
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-2026-P-4800-0002 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 Acknowledgement Letter from FDA DMB to Unison Pharmaceuticals Pvt. Ltd. Other Acknowledgement Letter/Receipt 2026-05-04T04:00:00Z 2026 5 2026-05-04T04:00:00Z   2026-05-04T21:20:40Z   0 0 09000064b92c0bf1
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

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options:

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;
Powered by Datasette · Queries took 823.6ms · Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API