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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

7 rows where docket_id = "FDA-2025-P-7054" sorted by posted_date descending

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

document_type 3

  • Other 3
  • Supporting & Related Material 3
  • Notice 1

posted_year 2

  • 2025 5
  • 2026 2

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2025-P-7054-0006 FDA Request that the FDA determine whether the Reference Listed Drug (RLD) MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under New Drug Application (NDA) N020850 held by Boehringer Ingelheim, was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons FDA-2025-P-7054 Determination That MICARDIS (Telmisartan), Tablets, 20 Milligrams and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2026-05-07T04:00:00Z 2026 5 2026-05-07T04:00:00Z   2026-05-07T17:15:35Z 2026-09011 0 0 09000064b92c66bf
FDA-2025-P-7054-0007 FDA Request that the FDA determine whether the Reference Listed Drug (RLD) MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under New Drug Application (NDA) N020850 held by Boehringer Ingelheim, was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons FDA-2025-P-7054 Response Letter from FDA CDER to Unichem Pharmaceuticals (USA), Inc. Other Letter(s) 2026-05-07T04:00:00Z 2026 5 2026-05-07T04:00:00Z   2026-05-07T21:33:35Z   0 0 09000064b92c7e5d
FDA-2025-P-7054-0004 FDA Request that the FDA determine whether the Reference Listed Drug (RLD) MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under New Drug Application (NDA) N020850 held by Boehringer Ingelheim, was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons FDA-2025-P-7054 Attachment 1 - Copies of relevant pages of Orange Book 45th Edition Cumulative Supplement 10, October 2025 Supporting & Related Material Background Material 2025-12-15T05:00:00Z 2025 12     2025-12-15T23:41:42Z   0 0 09000064b90d40f4
FDA-2025-P-7054-0001 FDA Request that the FDA determine whether the Reference Listed Drug (RLD) MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under New Drug Application (NDA) N020850 held by Boehringer Ingelheim, was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons FDA-2025-P-7054 Citizen Petition from Unichem Pharmaceuticals (USA), Inc. Other Citizen Petition 2025-12-15T05:00:00Z 2025 12 2025-12-15T05:00:00Z   2025-12-15T23:41:19Z   1 0 09000064b90d0b3d
FDA-2025-P-7054-0002 FDA Request that the FDA determine whether the Reference Listed Drug (RLD) MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under New Drug Application (NDA) N020850 held by Boehringer Ingelheim, was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons FDA-2025-P-7054 Acknowledgment Letter from FDA DMB to Unichem Pharmaceuticals (USA), Inc. Other Acknowledgement Letter/Receipt 2025-12-15T05:00:00Z 2025 12 2025-12-15T05:00:00Z   2025-12-15T23:41:31Z   0 0 09000064b90d0b43
FDA-2025-P-7054-0003 FDA Request that the FDA determine whether the Reference Listed Drug (RLD) MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under New Drug Application (NDA) N020850 held by Boehringer Ingelheim, was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons FDA-2025-P-7054 Telmisartan Agency Response Nov 28 2025 (1) Supporting & Related Material Background Material 2025-12-15T05:00:00Z 2025 12     2025-12-15T23:41:39Z   0 0 09000064b90d40f3
FDA-2025-P-7054-0005 FDA Request that the FDA determine whether the Reference Listed Drug (RLD) MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under New Drug Application (NDA) N020850 held by Boehringer Ingelheim, was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons FDA-2025-P-7054 Attachment 2 - Copies of relevant pages of current Orange Book for approved generic applications of Telmisartan Tablets, 20 mg and 80 mg. Supporting & Related Material Background Material 2025-12-15T05:00:00Z 2025 12     2025-12-15T23:41:46Z   0 0 09000064b90d40f5

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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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