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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

22 rows where docket_id = "FDA-1977-N-0356" sorted by posted_date descending

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posted_year 4

  • 2011 11
  • 2015 5
  • 2020 5
  • 2019 1

document_type 3

  • Other 18
  • Notice 2
  • Supporting & Related Material 2

agency_id 1

  • FDA 22
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1977-N-0356-0019 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Letter from K & L Gates to FDA CDER Other Letter(s) 2020-07-21T04:00:00Z 2020 7 2020-07-21T04:00:00Z   2020-07-21T14:17:11Z   0 0 090000648478c167
FDA-1977-N-0356-0022 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Letter from Lumara Health, AMAG Pharmaceuticals Other Letter(s) 2020-07-21T04:00:00Z 2020 7 2020-07-21T04:00:00Z   2020-07-21T14:23:49Z   0 0 090000648478cf79
FDA-1977-N-0356-0020 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Letter from K & L Gates to FDA CDER Other Letter(s) 2020-07-21T04:00:00Z 2020 7 2020-07-21T04:00:00Z   2020-07-21T14:19:16Z   0 0 090000648478c168
FDA-1977-N-0356-0021 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Letter from KV Pharmaceutical to FDA CDER Other Letter(s) 2020-07-21T04:00:00Z 2020 7 2020-07-21T04:00:00Z   2020-07-21T14:21:33Z   0 0 090000648478c169
FDA-1977-N-0356-0018 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Letter from Time-Cap Labs, Inc. (King & Spalding) to FDA Other Letter(s) 2020-01-13T05:00:00Z 2020 1 2020-01-13T05:00:00Z   2020-01-13T21:07:32Z   0 0 090000648428a8cd
FDA-1977-N-0356-0017 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 FDA to Time-Cap Other Letter(s) 2019-12-16T05:00:00Z 2019 12 2019-12-16T05:00:00Z   2019-12-16T15:57:55Z   0 0 09000064842138ca
FDA-1977-N-0356-0016 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Drugs for Human Use; Drug Efficacy Study Implementation; Nitroglycerin Transdermal Systems; Withdrawal of Hearing Request; Withdrawal of Applications; Final Resolution of Hearing Requests Regarding Transdermal Systems Under Docket Notice Announcement 2015-11-16T05:00:00Z 2015 11 2015-11-16T05:00:00Z   2024-11-07T23:35:36Z 2015-28853 1 0 0900006481d488ba
FDA-1977-N-0356-0015 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Letter from FDA CDER to Sandoz Inc. Other Letter(s) 2015-10-22T04:00:00Z 2015 10 2015-10-22T04:00:00Z   2015-10-22T18:51:06Z   0 0 0900006481ce26c2
FDA-1977-N-0356-0012 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Correspondence from Zuckerman Spaeder LLP to FDA CDER Other Correspondence 2015-04-09T04:00:00Z 2015 4 2015-04-09T04:00:00Z   2015-04-09T17:09:18Z   0 0 09000064810080e6
FDA-1977-N-0356-0013 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Request for Hearing from Lumara Health Inc Other Request for Hearing 2015-04-09T04:00:00Z 2015 4 2015-04-09T04:00:00Z   2015-05-13T14:52:12Z   0 0 0900006481a98273
FDA-1977-N-0356-0014 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Withdrawal of Hearing Request from Lumara Health Inc Other Withdrawal 2015-04-09T04:00:00Z 2015 4 2015-04-09T04:00:00Z   2015-05-13T14:51:10Z   0 0 0900006481a98274
FDA-1977-N-0356-0008 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 FDA/CDER Letter to Time-Cap Labs. Inc. - [King & Spalding, LLP] - Letter Other Letter(s) 2011-08-30T04:00:00Z 2011 8 2011-08-30T04:00:00Z   2024-11-07T22:32:35Z   1 0 0900006480f090b0
FDA-1977-N-0356-0007 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 FDA/CDER Letter to Schwarz Pharma, Inc., [Kleinfeld, Kaplan & Becker, LLP] - Letter - Letter Other Letter(s) 2011-08-30T04:00:00Z 2011 8 2011-08-30T04:00:00Z   2011-08-30T19:58:03Z   0 0 0900006480f090ac
FDA-1977-N-0356-0009 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 FDA/CDER Letter to Eon Labs Manufacturing. Inc. - [K&L Gates] - Letter Other Letter(s) 2011-08-30T04:00:00Z 2011 8 2011-08-30T04:00:00Z   2011-08-30T19:25:38Z   0 0 0900006480f090ca
FDA-1977-N-0356-0005 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 FDA/CDER Letter to KV Pharmaceutical Company - [ Zuckerman Spaeder LLP] - Letter Other Letter(s) 2011-08-30T04:00:00Z 2011 8 2011-08-30T04:00:00Z   2024-11-07T22:19:01Z   1 0 0900006480f0909b
FDA-1977-N-0356-0010 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 FDA/CDER Letter to Hereon Laboratories - [ Kleinfeld, Kaplan & Becker, LLP] - Letter Other Letter(s) 2011-08-30T04:00:00Z 2011 8 2011-08-30T04:00:00Z   2011-08-30T19:58:59Z   0 0 0900006480f090ce
FDA-1977-N-0356-0011 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 FDA/CDER Letter to Eon Labs Manufacturing. Inc. - [K&L Gates] - Letter Other Letter(s) 2011-08-30T04:00:00Z 2011 8     2011-08-30T19:31:19Z   0 0 0900006480f090ea
FDA-1977-N-0356-0006 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 FDA/CDER Letter to KV Pharmaceutical Company - [Buc & Beardsley, LLP] - Letter Other Letter(s) 2011-08-30T04:00:00Z 2011 8 2011-08-30T04:00:00Z   2024-11-12T05:02:48Z   1 0 0900006480f090aa
FDA-1977-N-0356-0002 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Letter from King & Spalding on behalf of Time-Cap Labs, Inc. to FDA Other Letter(s) 2011-04-06T04:00:00Z 2011 4 2011-04-06T04:00:00Z   2019-05-06T16:43:31Z   0 0 0900006480c10fc9
FDA-1977-N-0356-0004 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Attachment 2- Letter from King & Spalding, LLP to FDA, dated May 17, 1999 - [Time-Cap Labs, Inc. (King & Spalding, LLP) - Letter] Supporting & Related Material LET-Letter (Supporting and Related Material) 2011-04-06T04:00:00Z 2011 4     2011-04-06T16:45:48Z   0 0 0900006480c10fcd
FDA-1977-N-0356-0003 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Attachment 1 - FDA/CDER Response to King & Spalding, LLP, dated January 10, 2011 - [Time-Cap Labs, Inc. (King & Spalding, LLP) - Letter] Supporting & Related Material LET-Letter (Supporting and Related Material) 2011-04-06T04:00:00Z 2011 4     2011-04-06T16:45:47Z   0 0 0900006480c10fca
FDA-1977-N-0356-0001 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Certain Single-Entity Coronary Vasodilators Containing Controlled-Release Nitroglycerin; Opportunity for a Hearing Notice Notice of Opportunity of Hearing 2011-03-25T04:00:00Z 2011 3 2011-03-25T04:00:00Z 1999-06-22T03:59:59Z 2019-05-06T16:30:57Z 99-9770 0 0 09000064805ee900

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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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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