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41 rows where docket_id = "FDA-2018-N-3240" sorted by posted_date descending
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document_type 3
- Supporting & Related Material 25
- Notice 10
- Other 6
agency_id 1
- FDA 41
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2018-N-3240-0376 | FDA | None FDA-2018-N-3240 | Reference 1 - FDA Proposal Not to Include Ephedrine Sulfate on the 503B Bulks List RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2023-08-28T04:00:00Z | 2023 | 8 | 2023-08-28T16:19:35Z | 0 | 0 | 0900006485f02240 | |||
| FDA-2018-N-3240-0375 | FDA | None FDA-2018-N-3240 | Reference 3 - Part 1 Evaluation for Hydroxychloroquine Sulfate RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2023-08-23T04:00:00Z | 2023 | 8 | 2023-08-23T20:14:40Z | 0 | 0 | 0900006485edb7aa | |||
| FDA-2018-N-3240-0374 | FDA | None FDA-2018-N-3240 | Reference 2 - Supplemental clinical need evaluation for ephedrine sulfate in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2023-08-21T04:00:00Z | 2023 | 8 | 2023-08-21T19:04:48Z | 0 | 0 | 0900006485ecb128 | |||
| FDA-2018-N-3240-0373 | FDA | None FDA-2018-N-3240 | List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice | General Notice | 2023-08-21T04:00:00Z | 2023 | 8 | 2023-08-21T12:58:21Z | 2023-17881 | 0 | 0 | 0900006485ec9ee6 | ||
| FDA-2018-N-3240-0371 | FDA | None FDA-2018-N-3240 | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice | Announcement | 2023-04-06T04:00:00Z | 2023 | 4 | 2023-04-06T04:00:00Z | 2023-04-10T14:30:49Z | 2023-07217 | 0 | 0 | 09000064858f25e1 | |
| FDA-2018-N-3240-0372 | FDA | None FDA-2018-N-3240 | Reference 4 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Prescription Requirements Under Section 503 A Under the Federal Food Drug and Cosmetic Act | Supporting & Related Material | Background Material | 2023-04-06T04:00:00Z | 2023 | 4 | 2023-04-06T15:50:49Z | 0 | 0 | 09000064858f2ed2 | |||
| FDA-2018-N-3240-0369 | FDA | None FDA-2018-N-3240 | List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice | General Notice | 2022-11-23T05:00:00Z | 2022 | 11 | 2022-11-23T05:00:00Z | 2023-01-24T04:59:59Z | 2023-01-24T02:01:08Z | 2022-25549 | 0 | 0 | 09000064854fe4c0 |
| FDA-2018-N-3240-0367 | FDA | None FDA-2018-N-3240 | Reference 7 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2022-11-21T05:00:00Z | 2022 | 11 | 2022-11-21T20:47:57Z | 0 | 0 | 09000064854f8e4b | |||
| FDA-2018-N-3240-0368 | FDA | None FDA-2018-N-3240 | Reference 8 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2022-11-21T05:00:00Z | 2022 | 11 | 2022-11-21T20:48:00Z | 0 | 0 | 09000064854f8e4c | |||
| FDA-2018-N-3240-0363 | FDA | None FDA-2018-N-3240 | Reference 3 re List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2022-11-21T05:00:00Z | 2022 | 11 | 2022-11-21T20:47:44Z | 0 | 0 | 09000064854f8e47 | |||
| FDA-2018-N-3240-0364 | FDA | None FDA-2018-N-3240 | Reference 4 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2022-11-21T05:00:00Z | 2022 | 11 | 2022-11-21T20:47:48Z | 0 | 0 | 09000064854f8e48 | |||
| FDA-2018-N-3240-0365 | FDA | None FDA-2018-N-3240 | Reference 5 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2022-11-21T05:00:00Z | 2022 | 11 | 2022-11-21T20:47:51Z | 0 | 0 | 09000064854f8e49 | |||
| FDA-2018-N-3240-0366 | FDA | None FDA-2018-N-3240 | Reference 6 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2022-11-21T05:00:00Z | 2022 | 11 | 2022-11-21T20:47:54Z | 0 | 0 | 09000064854f8e4a | |||
| FDA-2018-N-3240-0362 | FDA | None FDA-2018-N-3240 | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice | General Notice | 2022-01-27T05:00:00Z | 2022 | 1 | 2022-01-27T05:00:00Z | 2022-01-27T15:00:40Z | 2022-01558 | 0 | 0 | 0900006484f3c6ef | |
| FDA-2018-N-3240-0284 | FDA | None FDA-2018-N-3240 | Reference 2 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2021-03-25T04:00:00Z | 2021 | 3 | 2021-03-25T13:05:02Z | 0 | 0 | 0900006484a79779 | |||
| FDA-2018-N-3240-0285 | FDA | None FDA-2018-N-3240 | Reference 3 re List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2021-03-25T04:00:00Z | 2021 | 3 | 2021-03-25T13:06:50Z | 0 | 0 | 0900006484a7a04d | |||
| FDA-2018-N-3240-0286 | FDA | None FDA-2018-N-3240 | Reference 4 re List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2021-03-25T04:00:00Z | 2021 | 3 | 2021-03-25T13:07:55Z | 0 | 0 | 0900006484a7a04f | |||
| FDA-2018-N-3240-0287 | FDA | None FDA-2018-N-3240 | Reference 5 re List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2021-03-25T04:00:00Z | 2021 | 3 | 2021-03-25T13:08:59Z | 0 | 0 | 0900006484a7a050 | |||
| FDA-2018-N-3240-0283 | FDA | None FDA-2018-N-3240 | Reference 1 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic | Supporting & Related Material | Background Material | 2021-03-25T04:00:00Z | 2021 | 3 | 2021-03-25T13:03:59Z | 0 | 0 | 0900006484a79778 | |||
| FDA-2018-N-3240-0282 | FDA | None FDA-2018-N-3240 | List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Act | Notice | General Notice | 2021-03-24T04:00:00Z | 2021 | 3 | 2021-03-24T04:00:00Z | 2021-05-25T03:59:59Z | 2022-01-25T02:00:44Z | 2021-06060 | 0 | 0 | 0900006484a768eb |
| FDA-2018-N-3240-0280 | FDA | None FDA-2018-N-3240 | Nomination from Outsourcing Facilities Association | Other | Electronic Regulation from Form | 2021-02-26T05:00:00Z | 2021 | 2 | 2021-02-26T05:00:00Z | 2021-02-26T22:06:59Z | 0 | 0 | 0900006484a217d2 | ||
| FDA-2018-N-3240-0274 | FDA | None FDA-2018-N-3240 | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Reopening of the Comment Period | Notice | General Notice | 2021-01-08T05:00:00Z | 2021 | 1 | 2021-01-08T05:00:00Z | 2021-02-09T04:59:59Z | 2021-03-02T02:00:57Z | 2021-00123 | 0 | 0 | 09000064849e8bca |
| FDA-2018-N-3240-0233 | FDA | None FDA-2018-N-3240 | Request for Extension from Outsourcing Facilities Association | Other | Request for Extension | 2020-09-29T04:00:00Z | 2020 | 9 | 2020-09-29T04:00:00Z | 2020-09-29T14:36:57Z | 0 | 0 | 0900006484892bae | ||
| FDA-2018-N-3240-0229 | FDA | None FDA-2018-N-3240 | Nomination from Wells Pharmacy Network | Other | Nomination | 2020-09-28T04:00:00Z | 2020 | 9 | 2020-09-28T04:00:00Z | 2020-09-28T21:21:19Z | 0 | 0 | 0900006484877b15 | ||
| FDA-2018-N-3240-0230 | FDA | None FDA-2018-N-3240 | Nomination from Wells Pharmacy Network | Other | Nomination | 2020-09-28T04:00:00Z | 2020 | 9 | 2020-09-28T04:00:00Z | 2020-09-28T21:25:48Z | 0 | 0 | 09000064848792b0 | ||
| FDA-2018-N-3240-0226 | FDA | None FDA-2018-N-3240 | Nomination from Wells Pharmacy Network | Other | Nomination | 2020-09-21T04:00:00Z | 2020 | 9 | 2020-09-21T04:00:00Z | 2020-09-21T17:14:54Z | 0 | 0 | 0900006484865f7e | ||
| FDA-2018-N-3240-0151 | FDA | None FDA-2018-N-3240 | Nomination from iVitalize, Inc. | Other | Nomination | 2020-08-28T04:00:00Z | 2020 | 8 | 2020-08-28T04:00:00Z | 2020-08-28T17:07:01Z | 0 | 0 | 09000064848269f1 | ||
| FDA-2018-N-3240-0058 | FDA | None FDA-2018-N-3240 | Reference 9 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T13:13:58Z | 0 | 0 | 09000064847c3cfe | |||
| FDA-2018-N-3240-0057 | FDA | None FDA-2018-N-3240 | Reference 10 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T13:13:57Z | 0 | 0 | 09000064847c3cff | |||
| FDA-2018-N-3240-0061 | FDA | None FDA-2018-N-3240 | Reference 6 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T13:13:59Z | 0 | 0 | 09000064847c3cfb | |||
| FDA-2018-N-3240-0059 | FDA | None FDA-2018-N-3240 | Reference 8 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T13:13:58Z | 0 | 0 | 09000064847c3cfd | |||
| FDA-2018-N-3240-0060 | FDA | None FDA-2018-N-3240 | Reference 7 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T13:13:59Z | 0 | 0 | 09000064847c3cfc | |||
| FDA-2018-N-3240-0056 | FDA | None FDA-2018-N-3240 | Reference 11 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T13:13:57Z | 0 | 0 | 09000064847c3d00 | |||
| FDA-2018-N-3240-0055 | FDA | None FDA-2018-N-3240 | Reference 12 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T13:13:56Z | 0 | 0 | 09000064847c3d01 | |||
| FDA-2018-N-3240-0063 | FDA | None FDA-2018-N-3240 | Reference 4 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T13:14:00Z | 0 | 0 | 09000064847c1a0f | |||
| FDA-2018-N-3240-0064 | FDA | None FDA-2018-N-3240 | Reference 3 re: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T13:14:01Z | 0 | 0 | 09000064847c1a0e | |||
| FDA-2018-N-3240-0062 | FDA | None FDA-2018-N-3240 | Reference 5 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Supporting & Related Material | Background Material | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T13:14:00Z | 0 | 0 | 09000064847c1a10 | |||
| FDA-2018-N-3240-0054 | FDA | None FDA-2018-N-3240 | List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice | General Notice | 2020-07-31T04:00:00Z | 2020 | 7 | 2020-07-31T04:00:00Z | 2020-09-30T03:59:59Z | 2020-11-21T02:01:53Z | 2020-16649 | 0 | 0 | 09000064847c3b71 |
| FDA-2018-N-3240-0033 | FDA | None FDA-2018-N-3240 | List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice | Request for Comments | 2019-09-03T04:00:00Z | 2019 | 9 | 2019-09-03T04:00:00Z | 2019-11-05T04:59:59Z | 2019-11-07T02:01:16Z | 2019-18932 | 0 | 0 | 0900006483ee2455 |
| FDA-2018-N-3240-0032 | FDA | None FDA-2018-N-3240 | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice | General Notice | 2019-03-04T05:00:00Z | 2019 | 3 | 2019-03-04T05:00:00Z | 2019-03-04T14:44:03Z | 2019-03810 | 0 | 0 | 0900006483abadd9 | |
| FDA-2018-N-3240-0001 | FDA | None FDA-2018-N-3240 | List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice | General Notice | 2018-08-28T04:00:00Z | 2018 | 8 | 2018-08-28T04:00:00Z | 2018-10-30T03:59:59Z | 2020-11-22T04:06:59Z | 2018-18614 | 0 | 0 | 0900006483662c5a |
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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;