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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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