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

12 rows where docket_id = "FDA-2006-P-0275" 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

document_type 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2006-P-0275-0010 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Background Materials re: Citizen Petition from KV Pharmaceutical Company:: Attachment D - Relevant portions of Reply Brief for the Apellants (FDA) at 35, Ranbaxy Labs. Ltd. v. Leavitt, No. 06-5154 (D.C. Cir. July 27, 2006) Supporting & Related Material Background Material 2008-12-17T05:00:00Z 2008 12     2024-12-05T15:11:22Z   0 0 090000648045828c
FDA-2006-P-0275-0012 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Background Materials re: Citizen Petition from KV Pharmaceutical Company:: Attachment A - Ranbaxy Labs. Ltd. v. Leavitt, No. 05-1838, 2006 U.S. Dist. LEXIS 24612, *28-29 (D.D.C. May 1, 2006) appeal pending, No. 06-5154 (D.C. Cir.) Supporting & Related Material Background Material 2008-12-17T05:00:00Z 2008 12     2024-12-05T15:13:05Z   0 0 0900006480458290
FDA-2006-P-0275-0008 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Background Materials re: Citizen Petition from KV Pharmaceutical Company: Attachment C - Relevant portions of Brief for the Apellants (FDA) at 32, Ranbaxy Labs. Ltd. v. Leavitt, No. 06-5154 (D.C. Cir. June 21, 2006) Supporting & Related Material Background Material 2008-12-17T05:00:00Z 2008 12     2024-12-05T15:09:21Z   0 0 0900006480458283
FDA-2006-P-0275-0009 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Background Materials re: Citizen Petition from KV Pharmaceutical Company:: Attachment E - FDA Letter from Gary Buehler, Dir., Office of Generic Drugs, to Tammy McIntire, Apotex Corp. at 2 (Apr. 11, 2006) Supporting & Related Material Background Material 2008-12-17T05:00:00Z 2008 12     2024-12-05T15:10:31Z   0 0 090000648045828a
FDA-2006-P-0275-0007 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Citizen Petition from KV Pharmaceutical Company Other Citizen Petition 2008-12-17T05:00:00Z 2008 12 2008-12-17T05:00:00Z   2024-12-05T15:07:54Z   0 0 0900006480458291
FDA-2006-P-0275-0011 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Background Materials re: Citizen Petition from KV Pharmaceutical Company:: Attachment B - 2005P-0008, Vol. 1, LET 3 Supporting & Related Material Background Material 2008-12-17T05:00:00Z 2008 12     2024-12-05T15:12:11Z   0 0 090000648045828e
FDA-2006-P-0275-0006 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Citizen Petition Denial from FDA CDER to KV Pharmaceutical Co Other Denial of Petition 2007-12-17T05:00:00Z 2007 12     2024-12-05T14:53:49Z   0 0 090000648045829b
FDA-2006-P-0275-0005 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Letter from FDA CDER to KV Pharmaceutical Co Other Letter(s) 2007-04-17T04:00:00Z 2007 4     2024-12-05T14:52:11Z   0 0 0900006480458299
FDA-2006-P-0275-0003 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Acknowledgment Letter Correction from FDA DMB to KV Pharmaceutical Company Other Correction(s) 2006-10-23T04:00:00Z 2006 10     2024-12-05T14:47:40Z   0 0 0900006480458295
FDA-2006-P-0275-0004 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Acknowledgment Letter Correction from FDA DMB to KV Pharmaceutical Company Other Correction(s) 2006-10-23T04:00:00Z 2006 10     2024-12-05T14:49:26Z   0 0 0900006480458297
FDA-2006-P-0275-0002 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Acknowledgment Letter from FDA DMB to KV Pharmaceutical Company Other Acknowledgement Letter/Receipt 2006-10-20T04:00:00Z 2006 10     2024-12-05T14:45:50Z   0 0 0900006480458294
FDA-2006-P-0275-0001 FDA Refrain from Approval of Any Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended Release100 mg & 200 mg Tablets Subsequent to ANDA 76-640 from K. V. Pharmaceuticals-CLOSED FDA-2006-P-0275 Acknowledgment Letter from FDA DMB to KV Pharmaceutical Company Other Acknowledgement Letter/Receipt 2006-10-20T04:00:00Z 2006 10     2024-12-05T14:42:16Z   0 0 0900006480458263

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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);