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22 rows where docket_id = "FDA-1977-N-0356" sorted by posted_date descending
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document_type 3
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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;