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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

12 rows where docket_id = "FDA-2002-P-0007" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, withdrawn, posted_date (date), comment_start_date (date), last_modified (date)

posted_year 4

  • 2004 7
  • 2011 3
  • 2002 1
  • 2013 1

document_type 2

  • Other 9
  • Supporting & Related Material 3

agency_id 1

  • FDA 12
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2002-P-0007-0013 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 FDA/CDER Response to The Weinberg Group Inc - Denial of Reconsideration Other Denial of Petition 2013-02-21T05:00:00Z 2013 2 2013-02-21T05:00:00Z   2013-02-21T18:23:51Z   0 0 09000064811fec32
FDA-2002-P-0007-0010 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Attachment 2 Cefuroxime Axetil Tablets for Oral Suspension [The Weinberg Group Inc. CP 1] Supporting & Related Material Background Material 2011-01-14T05:00:00Z 2011 1     2024-08-26T18:47:34Z   0 0 0900006480487413
FDA-2002-P-0007-0009 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Citizens Petition from The Weinberg Group Inc. Other CP-Citizen Petition 2011-01-14T05:00:00Z 2011 1 2011-01-14T05:00:00Z   2024-08-26T18:30:04Z   0 0 0900006480487421
FDA-2002-P-0007-0011 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Petition for Reconsideration from The Weinberg Group Inc. Other PRC-Petition for Reconsideration 2011-01-14T05:00:00Z 2011 1 2011-01-14T05:00:00Z   2024-08-26T18:31:23Z   0 0 090000648048742a
FDA-2002-P-0007-0008 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Letter from FDA DDM to The Weinberg Group Inc. Other Acknowledgement Letter/Receipt 2004-06-02T04:00:00Z 2004 6     2024-08-26T18:24:50Z   0 0 090000648048743a
FDA-2002-P-0007-0004 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Acknowledgement Letter from FDA DDM to The Weinberg Group Inc. Other Acknowledgement Letter/Receipt 2004-06-02T04:00:00Z 2004 6     2024-08-26T18:17:02Z   0 0 090000648048742f
FDA-2002-P-0007-0005 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Attachment 1 Cefuroxime Axetil Tablets for Oral Suspension [The Weinberg Group Inc. PRC 1) Supporting & Related Material Background Material 2004-06-02T04:00:00Z 2004 6     2024-08-26T18:45:47Z   0 0 0900006480487432
FDA-2002-P-0007-0006 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Attachment 2 "Madlon-Kay, D.J and Mosch, F.S. D- Liquid Medication Dosing Errors" The Weinberg Group Inc. Supporting & Related Material Background Material 2004-06-02T04:00:00Z 2004 6     2024-08-26T18:46:21Z   0 0 0900006480487435
FDA-2002-P-0007-0007 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 SEE FDA-2002-P-0007-0004 Other   2004-06-02T00:00:00Z 2004 6     2011-01-14T20:19:11Z   0 1 0900006480487437
FDA-2002-P-0007-0003 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Petition Denial from FDA CDER to The Weinberg Group, Inc. Other PDN-Petition Denial 2004-05-04T04:00:00Z 2004 5     2024-08-26T17:53:09Z   0 0 0900006480487428
FDA-2002-P-0007-0002 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Interim Response to The Weinberg Group Inc (CP1) Other LET-Letter 2004-02-05T05:00:00Z 2004 2     2024-08-26T17:51:54Z   0 0 0900006480487423
FDA-2002-P-0007-0001 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Acknowledgement Letter from FDA DMB to the Weinberg Group Inc. Other Acknowledgement Letter/Receipt 2002-09-16T04:00:00Z 2002 9     2024-09-06T14:52:47Z   0 0 0900006480487409

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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);
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