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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

2 rows where docket_id = "FDA-2012-P-1267" and posted_year = 2012 sorted by posted_date descending

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

posted_year 1

  • 2012 · 2 ✖

document_type 1

  • Other 2

agency_id 1

  • FDA 2
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2012-P-1267-0001 FDA Request Permission to File an Abbreviated New Drug Application (ANDA) Proposed Drug Product (Aspirin, Hydrocodone Bitartrate Tablets, 325 mg/ 5 mg) Suitable as the Current ANDA A089-420 Held by UCB Pharmaceuticals, Formerly Schwarz Pharma, Azdone™ (Aspirin, Hydrocodone Bitartrate Tablets, 500 mg/ 5 mg) - Citizen Petition, CLOSED: 7/9/2103 FDA-2012-P-1267 Xspire Pharma, LLC - Citizen Petition Other Citizen Petition 2012-12-31T05:00:00Z 2012 12 2012-12-31T05:00:00Z   2024-11-12T05:11:10Z   1 0 090000648119ff73
FDA-2012-P-1267-0002 FDA Request Permission to File an Abbreviated New Drug Application (ANDA) Proposed Drug Product (Aspirin, Hydrocodone Bitartrate Tablets, 325 mg/ 5 mg) Suitable as the Current ANDA A089-420 Held by UCB Pharmaceuticals, Formerly Schwarz Pharma, Azdone™ (Aspirin, Hydrocodone Bitartrate Tablets, 500 mg/ 5 mg) - Citizen Petition, CLOSED: 7/9/2103 FDA-2012-P-1267 Acknowledgement Letter to Xspire Pharma, LLC Other Acknowledgement Letter/Receipt 2012-12-31T05:00:00Z 2012 12 2012-12-31T05:00:00Z   2012-12-31T19:41:32Z   0 0 090000648119ff76

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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    withdrawn INTEGER,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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