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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

7 rows where docket_id = "FDA-2005-P-0366" sorted by posted_date descending

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

posted_year 3

  • 2010 3
  • 2005 2
  • 2006 2

document_type 1

  • Other 7

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0366-0005 FDA Require that generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) meet specific criteria in order to be considered bioequivalent to Wellbutrin XL-CLOSED FDA-2005-P-0366 Citizen Petition from Keller and Heckman LLP on behalf of Biovail Corporation Other Citizen Petition 2010-03-17T04:00:00Z 2010 3 2010-03-17T04:00:00Z   2025-04-24T18:52:49Z   0 0 090000648044af2c
FDA-2005-P-0366-0006 FDA Require that generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) meet specific criteria in order to be considered bioequivalent to Wellbutrin XL-CLOSED FDA-2005-P-0366 Tab 2 - Summary Report of Study No. AK1BOVAIL2548 re: Citizen Petition from Keller and Heckman LLP on behalf of Biovail Corporation Other Background Material 2010-03-17T04:00:00Z 2010 3 2010-03-17T04:00:00Z   2025-04-24T19:31:26Z   0 0 090000648044af2f
FDA-2005-P-0366-0007 FDA Require that generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) meet specific criteria in order to be considered bioequivalent to Wellbutrin XL-CLOSED FDA-2005-P-0366 Letter from Keller and Heckman LLP to FDA DDM Other Letter(s) 2010-03-17T04:00:00Z 2010 3 2010-03-17T04:00:00Z   2025-04-24T19:33:22Z   0 0 090000648044af44
FDA-2005-P-0366-0004 FDA Require that generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) meet specific criteria in order to be considered bioequivalent to Wellbutrin XL-CLOSED FDA-2005-P-0366 Petition Approval from FDA/Associate Commissioner for Policy and Planning to Keller and Heckman LLP Other Approval 2006-12-18T05:00:00Z 2006 12     2025-04-24T18:45:27Z   0 0 090000648044af45
FDA-2005-P-0366-0003 FDA Require that generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) meet specific criteria in order to be considered bioequivalent to Wellbutrin XL-CLOSED FDA-2005-P-0366 FDA/Center for Drug Evaluation and Research to Keller and Heckman LLP - Letter Other LET-Letter 2006-06-12T04:00:00Z 2006 6     2013-07-27T20:43:33Z   0 0 090000648044af43
FDA-2005-P-0366-0002 FDA Require that generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) meet specific criteria in order to be considered bioequivalent to Wellbutrin XL-CLOSED FDA-2005-P-0366 Acknowledgement Letter from FDA DDM to Keller and Heckman LLP Other Acknowledgement Letter/Receipt 2005-12-20T05:00:00Z 2005 12     2025-04-24T18:29:38Z   0 0 090000648044af31
FDA-2005-P-0366-0001 FDA Require that generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) meet specific criteria in order to be considered bioequivalent to Wellbutrin XL-CLOSED FDA-2005-P-0366 Acknowledgement Letter from FDA DDM to Keller and Heckman LLP Other Acknowledgement Letter/Receipt 2005-12-20T00:00:00Z 2005 12     2025-05-09T01:17:11Z   0 0 090000648044aec8

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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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