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

27 rows where docket_id = "FDA-2006-P-0007" sorted by posted_date descending

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posted_year 5

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0007-0055 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Tab 3 re Supplement from ViroPharma Incorporated Supporting & Related Material Background Material 2014-01-31T05:00:00Z 2014 1     2014-02-01T00:32:45Z   0 0 0900006480441478
FDA-2006-P-0007-0053 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Supplement from ViroPharma Incorporated Other Supplement (SUP) 2014-01-31T05:00:00Z 2014 1 2014-01-31T05:00:00Z   2014-01-31T23:37:55Z   0 0 0900006480924c45
FDA-2006-P-0007-0062 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Comment from D. Robertson re Conference Call Transcript Supporting & Related Material Background Material 2014-01-31T05:00:00Z 2014 1     2014-02-01T00:52:43Z   0 0 0900006480441492
FDA-2006-P-0007-0056 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Comment from Diane Robertson Supporting & Related Material Electronic Comment (EC) 2014-01-31T05:00:00Z 2014 1     2014-02-01T00:32:52Z   0 0 0900006480441494
FDA-2006-P-0007-0052 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 FDA/CDER Interim Response to ViroPharm, Inc. Other   2012-04-12T00:00:00Z 2012 4     2012-05-04T13:23:32Z   0 1 0900006480fee22f
FDA-2006-P-0007-0051 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Petition Partial Approval and Denial from FDA/CDER to ViroPharma Inc. Other Partial Petition Approval and Denial 2012-04-09T04:00:00Z 2012 4 2012-04-09T04:00:00Z   2014-01-31T19:18:19Z   0 0 0900006480fec3d7
FDA-2006-P-0007-0026 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma Incorporated (ViroPharma) - Supplement Other SUP-Supplement 2009-01-06T05:00:00Z 2009 1 2009-01-06T05:00:00Z   2009-01-06T18:06:45Z   0 0 0900006480441477
FDA-2006-P-0007-0023 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma Incorporated - Supplement Petition Other SUP-Supplement 2009-01-06T05:00:00Z 2009 1 2009-01-06T05:00:00Z   2009-01-06T17:35:00Z   0 0 090000648081061f
FDA-2006-P-0007-0028 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma Inc. - Supplement Other SUP-Supplement 2009-01-06T05:00:00Z 2009 1 2009-01-06T05:00:00Z   2009-01-06T20:26:13Z   0 0 090000648044149b
FDA-2006-P-0007-0027 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma Incorporated (ViroPharma) - Supplement Other SUP-Supplement 2009-01-06T05:00:00Z 2009 1 2009-01-06T05:00:00Z   2009-01-06T18:12:03Z   0 0 0900006480441479
FDA-2006-P-0007-0025 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma Incorporated (ViroPharma) - Supplement Other SUP-Supplement 2009-01-06T05:00:00Z 2009 1 2009-01-06T05:00:00Z   2009-01-06T18:00:35Z   0 0 0900006480441476
FDA-2006-P-0007-0024 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma Incorporated (ViroPharma) - Supplement Other SUP-Supplement 2009-01-06T05:00:00Z 2009 1 2009-01-06T05:00:00Z   2009-01-06T17:45:41Z   0 0 0900006480441475
FDA-2006-P-0007-0022 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 See Document ID FDA-2008-D-0626-0002 re Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl Notice of Availability Reference Supporting & Related Material REF-Reference Material (external attachments) 2008-12-24T05:00:00Z 2008 12     2014-02-01T00:56:34Z   0 0 09000064807f2141
FDA-2006-P-0007-0019 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 FDA/ViroPharma - Minutes of Meeting Other MM-Memorandum of Meeting 2008-12-11T05:00:00Z 2008 12 2008-12-11T05:00:00Z   2008-12-21T03:21:44Z   0 0 09000064807d7b1e
FDA-2006-P-0007-0021 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma Slide Presentation Vancocin Bioequivalence (BE) Appropriate Method Development FDA Meeting January 7 2008 re FDA-2006-P-0007-0020 Supporting & Related Material C-Comment (Supporting and Related Material) 2008-12-11T05:00:00Z 2008 12     2014-02-01T00:54:04Z   0 0 09000064807d7d80
FDA-2006-P-0007-0020 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma Incorporated - Letter Other LET-Letter 2008-12-11T05:00:00Z 2008 12 2008-12-11T05:00:00Z   2010-11-03T16:48:34Z   0 0 09000064807d7d09
FDA-2006-P-0007-0018 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma Incorporated - Supplement Petition Other SUP-Supplement 2008-12-11T05:00:00Z 2008 12 2008-12-11T05:00:00Z   2013-07-27T22:19:34Z   0 0 090000648069607b
FDA-2006-P-0007-0016 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma - Supplement Other SUP-Supplement 2008-06-23T04:00:00Z 2008 6 2008-06-23T04:00:00Z   2008-06-24T00:30:39Z   0 0 090000648062bae0
FDA-2006-P-0007-0014 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Congressional Record - Senate (S5649-5650), May 7, 2007 - [D. Robertson - Comment] Supporting & Related Material EMC-E-Mail (Supporting and Related Material) 2008-04-16T04:00:00Z 2008 4     2009-02-10T17:36:41Z   0 0 0900006480441490
FDA-2006-P-0007-0006 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharm Incorporated - Letter Other LET-Letter 2008-04-16T04:00:00Z 2008 4 2008-04-16T04:00:00Z   2008-04-16T23:22:23Z   0 0 0900006480441455
FDA-2006-P-0007-0003 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Petition for stay from ViroPharma Incorporated Other PSA-Petition for Stay 2008-04-16T04:00:00Z 2008 4 2008-04-16T04:00:00Z   2019-07-08T14:48:05Z   0 0 0900006480441450
FDA-2006-P-0007-0007 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 ViroPharma, Inc. - SUP - Supplement Other SUP-Supplement 2008-04-16T04:00:00Z 2008 4 2008-04-16T04:00:00Z   2019-07-08T14:48:59Z   0 0 090000648044146d
FDA-2006-P-0007-0015 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 See FDA-2006-P-0007-0014 Supporting & Related Material EMC-E-Mail (Supporting and Related Material) 2008-04-16T04:00:00Z 2008 4     2009-02-10T17:37:31Z   0 0 0900006480441498
FDA-2006-P-0007-0004 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Petition for Stay from ViroPharma Incorporated March 30, 2006 Other PSA-Petition for Stay 2008-04-16T04:00:00Z 2008 4 2008-04-16T04:00:00Z   2019-07-08T14:48:34Z   0 0 0900006480441452
FDA-2006-P-0007-0005 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Acknowledgement Letter to ViroPharma Incorporated Other ACK-Acknowledgement Letter 2008-04-16T04:00:00Z 2008 4 2008-04-16T04:00:00Z   2008-06-24T00:32:45Z   0 0 0900006480441454
FDA-2006-P-0007-0001 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Acknowledgement Letter to ViroPharma Other ACK-Acknowledgement Letter 2006-03-17T05:00:00Z 2006 3     2014-02-01T21:21:53Z   0 0 090000648044144d
FDA-2006-P-0007-0002 FDA Stay any Approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules - CLOSED FDA-2006-P-0007 Acknowledgement Letter to ViroPharma Incorporated Other ACK-Acknowledgement Letter 2006-03-17T05:00:00Z 2006 3     2014-02-01T01:12:13Z   0 0 0900006480441451

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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);