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

4 rows where docket_id = "FDA-2005-P-0313" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, posted_date (date), last_modified (date)

posted_year 2

document_type 1

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2005-P-0313-0004 FDA FDA to Refuse to Approve ANDA or Section 505(b)(2), for Inhalation Drug Products Containing A Combination of the Active Ingredients Albuterol Sulfate & Ipratropium Hydrochloirde Administered by Nebulization for the Treatment of Chronic Pulmonary Obstructive Disorder-CLOSED FDA-2005-P-0313 Petition Denial from FDA CDER to Charles J. Raubicheck Other Denial 2006-12-26T05:00:00Z 2006 12     2024-12-16T16:54:26Z   0 0 0900006480447a06
FDA-2005-P-0313-0003 FDA FDA to Refuse to Approve ANDA or Section 505(b)(2), for Inhalation Drug Products Containing A Combination of the Active Ingredients Albuterol Sulfate & Ipratropium Hydrochloirde Administered by Nebulization for the Treatment of Chronic Pulmonary Obstructive Disorder-CLOSED FDA-2005-P-0313 Letter from FDA CDER to Frommer Lawrence and Haug LLP Other LET-Letter 2006-01-24T05:00:00Z 2006 1     2024-12-16T16:47:38Z   0 0 0900006480447a04
FDA-2005-P-0313-0001 FDA FDA to Refuse to Approve ANDA or Section 505(b)(2), for Inhalation Drug Products Containing A Combination of the Active Ingredients Albuterol Sulfate & Ipratropium Hydrochloirde Administered by Nebulization for the Treatment of Chronic Pulmonary Obstructive Disorder-CLOSED FDA-2005-P-0313 Acknowledgment Letter from FDA DDM to Frommer Lawrence and Haug LLP Other Acknowledgement Letter/Receipt 2005-07-26T04:00:00Z 2005 7     2024-12-16T16:41:15Z   0 0 09000064804479e3
FDA-2005-P-0313-0002 FDA FDA to Refuse to Approve ANDA or Section 505(b)(2), for Inhalation Drug Products Containing A Combination of the Active Ingredients Albuterol Sulfate & Ipratropium Hydrochloirde Administered by Nebulization for the Treatment of Chronic Pulmonary Obstructive Disorder-CLOSED FDA-2005-P-0313 Acknowledgment Letter from FDA DDM to Frommer Lawrence and Haug LLP Other Acknowledgement Letter/Receipt 2005-07-26T04:00:00Z 2005 7     2024-12-16T16:46:25Z   0 0 0900006480447a03

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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);