Home Applications 212327 Application 212327
Type NDA
Sponsor IMPACT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 INREBIC FEDRATINIB HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212327-001 INREBIC FEDRATINIB HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212327-001 7825246 2026-12-16 Drug substance 2019-08-27 N212327-001 8138199 2028-06-30 U-2607 2019-08-27 N212327-001 7528143 2031-11-16 Drug substance, Drug product 2019-08-27 N212327-001 10391094 2032-06-04 U-2607 Drug product 2019-09-04 N212327-001 11400092 2039-09-24 U-3409 2022-08-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212327-001 ODE-259 2026-08-16
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212327-001 INREBIC EQ 100MG BASE CAPSULE / ORAL RLD, RS 2019-08-16 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 187 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N212327-001 7825246 2026-12-16 Drug substance 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212327-001 8138199 2028-06-30 U-2607 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212327-001 7528143 2031-11-16 Drug substance, Drug product 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212327-001 10391094 2032-06-04 U-2607 Drug product 2019-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212327-001 11400092 2039-09-24 U-3409 2022-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212327-001 7825246 2026-12-16 Drug substance 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212327-001 8138199 2028-06-30 U-2607 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212327-001 7528143 2031-11-16 Drug substance, Drug product 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212327-001 10391094 2032-06-04 U-2607 Drug product 2019-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212327-001 11400092 2039-09-24 U-3409 2022-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212327-001 7825246 2026-12-16 Drug substance 2019-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212327-001 8138199 2028-06-30 U-2607 2019-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212327-001 7528143 2031-11-16 Drug substance, Drug product 2019-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212327-001 10391094 2032-06-04 U-2607 Drug product 2019-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212327-001 11400092 2039-09-24 U-3409 2022-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212327-001 7825246 2026-12-16 Drug substance 2019-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212327-001 8138199 2028-06-30 U-2607 2019-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212327-001 7528143 2031-11-16 Drug substance, Drug product 2019-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212327-001 10391094 2032-06-04 U-2607 Drug product 2019-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212327-001 11400092 2039-09-24 U-3409 2022-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212327-001 7825246 2026-12-16 Drug substance 2019-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212327-001 8138199 2028-06-30 U-2607 2019-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212327-001 7528143 2031-11-16 Drug substance, Drug product 2019-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212327-001 10391094 2032-06-04 U-2607 Drug product 2019-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212327-001 11400092 2039-09-24 U-3409 2022-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212327-001 7825246 2026-12-16 Drug substance 2019-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212327-001 8138199 2028-06-30 U-2607 2019-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212327-001 7528143 2031-11-16 Drug substance, Drug product 2019-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212327-001 10391094 2032-06-04 U-2607 Drug product 2019-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212327-001 11400092 2039-09-24 U-3409 2022-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212327-001 7825246 2026-12-16 Drug substance 2019-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212327-001 8138199 2028-06-30 U-2607 2019-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212327-001 7528143 2031-11-16 Drug substance, Drug product 2019-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212327-001 10391094 2032-06-04 U-2607 Drug product 2019-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212327-001 11400092 2039-09-24 U-3409 2022-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212327-001 7825246 2026-12-16 Drug substance 2019-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212327-001 8138199 2028-06-30 U-2607 2019-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212327-001 7528143 2031-11-16 Drug substance, Drug product 2019-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212327-001 10391094 2032-06-04 U-2607 Drug product 2019-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212327-001 11400092 2039-09-24 U-3409 2022-08-30 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 73 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Inrebic FEDRATINIB HYDROCHLORIDE Celgene Corporation f0f55a2a-4e0c-4cba-8571-03e1424486d7 2026-07-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 212327 application number: NDA212327 ndc (product): 59572-720
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59572-720 Inrebic Fedratinib Hydrochloride Celgene Corporation NDA Current 59572-720 Inrebic Fedratinib Hydrochloride Celgene Corporation NDA Current 59572-720 Inrebic Fedratinib Hydrochloride Celgene Corporation NDA Current 59572-720 Inrebic Fedratinib Hydrochloride Celgene Corporation NDA Current 59572-720 Inrebic Fedratinib Hydrochloride Celgene Corporation NDA Current 59572-720 Inrebic Fedratinib Hydrochloride Celgene Corporation NDA Current