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

8 rows where docket_id = "FDA-2025-P-6024" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-6024-0008 FDA Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA FDA-2025-P-6024 Final Response Other Denial 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-16T01:50:33Z   0 0 09000064b92dc6f6
FDA-2025-P-6024-0007 FDA Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA FDA-2025-P-6024 Completeness Assessment Correspondence Other Assessment Document or Analysis 2025-12-01T05:00:00Z 2025 12 2025-12-01T05:00:00Z   2025-12-01T20:24:41Z   0 0 09000064b90a5838
FDA-2025-P-6024-0004 FDA Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA FDA-2025-P-6024 Attachment 2 - Clemastine Fumarate labeling Supporting & Related Material Background Material 2025-11-12T05:00:00Z 2025 11     2025-11-13T01:55:07Z   0 0 09000064b907deb2
FDA-2025-P-6024-0005 FDA Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA FDA-2025-P-6024 Attachment 3 - Tavist labeling Supporting & Related Material Background Material 2025-11-12T05:00:00Z 2025 11     2025-11-13T01:55:09Z   0 0 09000064b907deb9
FDA-2025-P-6024-0002 FDA Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA FDA-2025-P-6024 Acknowledgement Letter from FDA DMB to Hyman, Phelps & McNamara, P.C. Other Acknowledgement Letter/Receipt 2025-11-12T05:00:00Z 2025 11 2025-11-12T05:00:00Z   2025-11-13T01:53:32Z   0 0 09000064b907de38
FDA-2025-P-6024-0001 FDA Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA FDA-2025-P-6024 Suitability Petition from Hyman, Phelps & McNamara, P.C. Other Petition(s) 2025-11-12T05:00:00Z 2025 11 2025-11-12T05:00:00Z   2025-11-13T01:50:10Z   1 0 09000064b907de37
FDA-2025-P-6024-0003 FDA Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA FDA-2025-P-6024 Attachment 1 - Tavist OB listing Supporting & Related Material Background Material 2025-11-12T05:00:00Z 2025 11     2025-11-13T01:55:05Z   0 0 09000064b907dea8
FDA-2025-P-6024-0006 FDA Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA FDA-2025-P-6024 Attachment 4 - Draft Clemastine Fumarate labeling Supporting & Related Material Background Material 2025-11-12T05:00:00Z 2025 11     2025-11-13T01:55:11Z   0 0 09000064b907debb

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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;