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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-6706" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-6706-0003 FDA Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717. FDA-2026-P-6706 Attachment 1 Supporting & Related Material Background Material 2026-06-11T04:00:00Z 2026 6     2026-06-11T21:14:39Z   0 0 09000064b9322c97
FDA-2026-P-6706-0004 FDA Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717. FDA-2026-P-6706 Attachment 2 Supporting & Related Material Background Material 2026-06-11T04:00:00Z 2026 6     2026-06-11T21:14:44Z   0 0 09000064b9324f61
FDA-2026-P-6706-0002 FDA Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717. FDA-2026-P-6706 Acknowledgement Letter from FDA DMB to Appco Pharma LLC Other Acknowledgement Letter/Receipt 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T21:14:34Z   0 0 09000064b9324f5d
FDA-2026-P-6706-0001 FDA Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717. FDA-2026-P-6706 Suitability Petition from Appco Pharma LLC Other Petition(s) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T21:14:18Z   1 0 09000064b9324f5a
FDA-2026-P-6706-0005 FDA Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717. FDA-2026-P-6706 Attachment 3 Supporting & Related Material Background Material 2026-06-11T04:00:00Z 2026 6     2026-06-11T21:14:50Z   0 0 09000064b9324f62

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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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