documents
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29 rows where docket_id = "FDA-2018-N-1262" sorted by posted_date descending
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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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2018-N-1262-0029 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; EYLEA HD (aflibercept) | Notice | Notice of Approval | 2025-04-23T04:00:00Z | 2025 | 4 | 2025-04-23T13:35:52Z | 2025-06969 | 0 | 0 | 0900006486aa96be | ||
| FDA-2018-N-1262-0028 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AMVUTTRA (vutrisiran) | Notice | Notice of Approval | 2025-04-21T04:00:00Z | 2025 | 4 | 2025-04-21T13:40:16Z | 2025-06785 | 0 | 0 | 0900006486aa4378 | ||
| FDA-2018-N-1262-0027 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; TREMFYA (guselkumab) | Notice | Notice of Approval | 2025-04-21T04:00:00Z | 2025 | 4 | 2025-04-21T13:37:12Z | 2025-06784 | 0 | 0 | 0900006486aa43b7 | ||
| FDA-2018-N-1262-0026 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor) | Notice | Announcement | 2025-01-10T05:00:00Z | 2025 | 1 | 2025-01-10T05:00:00Z | 2025-01-10T13:56:06Z | 2025-00341 | 0 | 0 | 09000064868addd8 | |
| FDA-2018-N-1262-0025 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KISQALI (ribociclib) | Notice | Notice of Approval | 2024-10-15T04:00:00Z | 2024 | 10 | 2024-10-15T14:35:39Z | 2024-23651 | 0 | 0 | 09000064867ce6bb | ||
| FDA-2018-N-1262-0024 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; TREMFYA (guselkumab) | Notice | Announcement | 2024-10-11T04:00:00Z | 2024 | 10 | 2024-10-11T04:00:00Z | 2024-10-11T14:35:40Z | 2024-23629 | 0 | 0 | 09000064867c9627 | |
| FDA-2018-N-1262-0023 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; OPZELURA (ruxolitinib) | Notice | General Notice | 2024-09-11T04:00:00Z | 2024 | 9 | 2024-09-11T13:16:31Z | 2024-20556 | 0 | 0 | 09000064866ea193 | ||
| FDA-2018-N-1262-0022 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) | Notice | Announcement | 2024-07-17T04:00:00Z | 2024 | 7 | 2024-07-17T04:00:00Z | 2024-07-17T13:00:19Z | 2024-15695 | 0 | 0 | 09000064865f4739 | |
| FDA-2018-N-1262-0018 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2024-01-23T05:00:00Z | 2024 | 1 | 2024-01-23T05:00:00Z | 2024-01-23T15:06:50Z | 2024-01156 | 0 | 0 | 09000064863b8649 | |
| FDA-2018-N-1262-0019 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2024-01-23T05:00:00Z | 2024 | 1 | 2024-01-23T05:00:00Z | 2024-01-23T15:31:45Z | 2024-01164 | 0 | 0 | 09000064863b88d4 | |
| FDA-2018-N-1262-0021 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2024-01-23T05:00:00Z | 2024 | 1 | 2024-01-23T05:00:00Z | 2024-01-23T15:57:05Z | 2024-01160 | 0 | 0 | 09000064863b9236 | |
| FDA-2018-N-1262-0020 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2024-01-23T05:00:00Z | 2024 | 1 | 2024-01-23T05:00:00Z | 2024-01-23T15:55:32Z | 2024-01163 | 0 | 0 | 09000064863b9166 | |
| FDA-2018-N-1262-0017 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2022-12-14T05:00:00Z | 2022 | 12 | 2022-12-14T05:00:00Z | 2022-12-14T14:00:50Z | 2022-27138 | 0 | 0 | 0900006485535ce4 | |
| FDA-2018-N-1262-0016 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2022-12-07T05:00:00Z | 2022 | 12 | 2022-12-07T05:00:00Z | 2022-12-07T16:17:58Z | 2022-26565 | 0 | 0 | 09000064855212b5 | |
| FDA-2018-N-1262-0015 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2022-11-25T05:00:00Z | 2022 | 11 | 2022-11-25T05:00:00Z | 2022-11-25T14:45:36Z | 2022-25644 | 0 | 0 | 0900006485500679 | |
| FDA-2018-N-1262-0014 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2022-09-08T04:00:00Z | 2022 | 9 | 2022-09-08T04:00:00Z | 2022-09-08T14:34:06Z | 2022-19384 | 0 | 0 | 09000064852c9f6b | |
| FDA-2018-N-1262-0013 | FDA | None FDA-2018-N-1262 | Issuance of Priority Review Voucher; Rare Pediatric Disease Product | Notice | Announcement | 2022-09-07T04:00:00Z | 2022 | 9 | 2022-09-07T04:00:00Z | 2022-09-07T12:52:36Z | 2022-19276 | 0 | 0 | 09000064852bf70e | |
| FDA-2018-N-1262-0012 | FDA | None FDA-2018-N-1262 | Issuance of Priority Review Voucher; Rare Pediatric Disease Product | Notice | Announcement | 2022-09-06T04:00:00Z | 2022 | 9 | 2022-09-06T04:00:00Z | 2022-09-06T13:34:10Z | 2022-19155 | 0 | 0 | 09000064852b409b | |
| FDA-2018-N-1262-0011 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2022-06-27T04:00:00Z | 2022 | 6 | 2022-06-27T04:00:00Z | 2022-06-27T13:14:32Z | 2022-13628 | 0 | 0 | 090000648519efa6 | |
| FDA-2018-N-1262-0010 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2022-06-24T04:00:00Z | 2022 | 6 | 2022-06-24T04:00:00Z | 2022-06-24T12:52:29Z | 2022-13607 | 0 | 0 | 090000648518bcf9 | |
| FDA-2018-N-1262-0009 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2020-06-01T04:00:00Z | 2020 | 6 | 2020-06-01T04:00:00Z | 2020-06-01T14:19:14Z | 2020-11681 | 0 | 0 | 09000064846bf562 | |
| FDA-2018-N-1262-0008 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2019-12-16T05:00:00Z | 2019 | 12 | 2019-12-16T05:00:00Z | 2019-12-16T15:12:52Z | 2019-27054 | 0 | 0 | 0900006484212720 | |
| FDA-2018-N-1262-0007 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Notice of Approval | 2019-10-25T04:00:00Z | 2019 | 10 | 2019-10-25T04:00:00Z | 2019-10-25T12:49:49Z | 2019-23252 | 0 | 0 | 09000064840f8b96 | |
| FDA-2018-N-1262-0006 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Announcement | 2019-09-06T04:00:00Z | 2019 | 9 | 2019-09-06T04:00:00Z | 2019-09-06T13:45:31Z | 2019-19298 | 0 | 0 | 0900006483f0482d | |
| FDA-2018-N-1262-0005 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Announcement | 2019-06-04T04:00:00Z | 2019 | 6 | 2019-06-04T04:00:00Z | 2019-06-04T13:21:02Z | 2019-11522 | 0 | 0 | 0900006483ce690b | |
| FDA-2018-N-1262-0004 | FDA | None FDA-2018-N-1262 | Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Announcement | 2019-05-03T04:00:00Z | 2019 | 5 | 2019-05-03T04:00:00Z | 2019-05-06T14:59:30Z | 2019-09005 | 0 | 0 | 0900006483c2de53 | |
| FDA-2018-N-1262-0003 | FDA | None FDA-2018-N-1262 | Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | Notice | Announcement | 2018-11-23T05:00:00Z | 2018 | 11 | 2018-11-23T05:00:00Z | 2018-11-23T20:50:10Z | 2018-25480 | 0 | 0 | 09000064838f5b5b | |
| FDA-2018-N-1262-0002 | FDA | None FDA-2018-N-1262 | Issuance of Priority Review Voucher; Rare Pediatric Disease Product | Notice | Announcement | 2018-10-25T04:00:00Z | 2018 | 10 | 2018-10-25T04:00:00Z | 2018-10-25T13:55:20Z | 2018-23308 | 0 | 0 | 09000064838490b7 | |
| FDA-2018-N-1262-0001 | FDA | None FDA-2018-N-1262 | Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers | Notice | Notice of Approval | 2018-04-10T04:00:00Z | 2018 | 4 | 2018-04-10T04:00:00Z | 2018-04-10T14:31:13Z | 2018-07256 | 0 | 0 | 09000064830f4b4a |
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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;