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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-5611" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-5611-0003 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) 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-5611-0004 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) 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 Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) 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-5611-0002 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 Acknowledgment Letter from FDA DMB to Senores Pharmaceuticals, Inc Other Acknowledgement Letter/Receipt 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:37:28Z   0 0 09000064b92d7cce
FDA-2026-P-5611-0001 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 Suitability Petition from Senores Pharmaceuticals, Inc Other Petition(s) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:37:18Z   1 0 09000064b92d9592

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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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