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

7 rows where agency_id = "FDA" and docket_id = "FDA-2006-P-0077" sorted by posted_date descending

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posted_year 3

document_type 2

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2006-P-0077-0007 FDA ANDA Suitability for Methotrexate Injection FDA-2006-P-0077 Memorandum of Withdrawal from FDA CDER to DDM Other Withdrawal 2015-12-21T05:00:00Z 2015 12 2015-12-21T05:00:00Z   2015-12-21T21:27:37Z   0 0 0900006481dbfa11
FDA-2006-P-0077-0005 FDA ANDA Suitability for Methotrexate Injection FDA-2006-P-0077 Suitability Petition from Sicor Pharmaceuticals, Inc. - Attachment 1 - Medical Rationale for the Proposed Product Included as Statement of Grounds Supporting & Related Material Background Material 2008-11-17T05:00:00Z 2008 11     2024-12-10T15:08:51Z   0 0 0900006480444708
FDA-2006-P-0077-0006 FDA ANDA Suitability for Methotrexate Injection FDA-2006-P-0077 Suitability Petition from Sicor Pharmaceuticals, Inc. - Attachment 2 - Proposed Package Insert for PCH's Methotrexate Injection, USP Supporting & Related Material Background Material 2008-11-17T05:00:00Z 2008 11     2024-12-10T15:07:16Z   0 0 0900006480444709
FDA-2006-P-0077-0003 FDA ANDA Suitability for Methotrexate Injection FDA-2006-P-0077 Suitability Petition from Sicor Pharmaceuticals, Inc. Other Citizen Petition 2008-11-17T05:00:00Z 2008 11 2008-11-17T05:00:00Z   2024-12-10T14:58:16Z   0 0 0900006480444707
FDA-2006-P-0077-0004 FDA ANDA Suitability for Methotrexate Injection FDA-2006-P-0077 Suitability Petition from Sicor Pharmaceuticals, Inc. - Attachment 3 - Mayne Pharma USA Methrotrexate Injection, USP, Preservative Free Package Insert Supporting & Related Material Citizen Petition 2008-11-17T05:00:00Z 2008 11     2024-12-10T15:10:32Z   0 0 0900006480444705
FDA-2006-P-0077-0002 FDA ANDA Suitability for Methotrexate Injection FDA-2006-P-0077 Acknowledgment Letter from FDA DMB to Sicor Pharmaceuticals, Inc. Other Acknowledgement Letter/Receipt 2006-12-11T05:00:00Z 2006 12     2024-12-10T14:56:54Z   0 0 090000648044470e
FDA-2006-P-0077-0001 FDA ANDA Suitability for Methotrexate Injection FDA-2006-P-0077 Acknowledgment Letter from FDA DMB to Sicor Pharmaceuticals, Inc. Other Acknowledgement Letter/Receipt 2006-12-11T05:00:00Z 2006 12     2024-12-10T14:55:59Z   0 0 0900006480444704

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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);