Home Applications 214120 Application 214120
Type NDA
Sponsor CELGENE CORP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ONUREG AZACITIDINE TABLET;ORAL 200MG No No 002 ONUREG AZACITIDINE TABLET; ORAL 300MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214120-001 ONUREG AZACITIDINE 200MG TABLET / ORAL RLD 2020-09-01 N214120-002 ONUREG AZACITIDINE 300MG TABLET / ORAL RLD, RS 2020-09-01
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214120-001 11571436 2029-05-14 Drug product 2023-02-10 N214120-001 12053482 2029-05-14 U-2950 2024-08-28 N214120-001 8846628 2030-06-03 U-2950 Drug product 2020-09-29 N214120-002 11571436 2029-05-14 Drug product 2023-02-10 N214120-002 12053482 2029-05-14 U-2950 2024-08-28 N214120-002 8846628 2030-06-03 U-2950 Drug product 2020-09-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214120-001 ODE-320 2027-09-01 N214120-002 ODE-320 2027-09-01
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.
Product history page 1 of 2 · 74 observed 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 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214120-001 ONUREG 200MG TABLET / ORAL RLD 2020-09-01 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214120-002 ONUREG 300MG TABLET / ORAL RLD, RS 2020-09-01 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 4 · 142 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 N214120-001 11571436 2029-05-14 Drug product 2023-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214120-001 12053482 2029-05-14 U-2950 2024-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214120-001 8846628 2030-06-03 U-2950 Drug product 2020-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214120-002 11571436 2029-05-14 Drug product 2023-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214120-002 12053482 2029-05-14 U-2950 2024-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214120-002 8846628 2030-06-03 U-2950 Drug product 2020-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214120-001 11571436 2029-05-14 Drug product 2023-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214120-001 12053482 2029-05-14 U-2950 2024-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214120-001 8846628 2030-06-03 U-2950 Drug product 2020-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214120-002 11571436 2029-05-14 Drug product 2023-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214120-002 12053482 2029-05-14 U-2950 2024-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214120-002 8846628 2030-06-03 U-2950 Drug product 2020-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214120-001 11571436 2029-05-14 Drug product 2023-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214120-001 12053482 2029-05-14 U-2950 2024-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214120-001 8846628 2030-06-03 U-2950 Drug product 2020-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214120-002 11571436 2029-05-14 Drug product 2023-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214120-002 12053482 2029-05-14 U-2950 2024-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214120-002 8846628 2030-06-03 U-2950 Drug product 2020-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214120-001 11571436 2029-05-14 Drug product 2023-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214120-001 12053482 2029-05-14 U-2950 2024-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214120-001 8846628 2030-06-03 U-2950 Drug product 2020-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214120-002 11571436 2029-05-14 Drug product 2023-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214120-002 12053482 2029-05-14 U-2950 2024-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214120-002 8846628 2030-06-03 U-2950 Drug product 2020-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214120-001 11571436 2029-05-14 Drug product 2023-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214120-001 12053482 2029-05-14 U-2950 2024-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214120-001 8846628 2030-06-03 U-2950 Drug product 2020-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214120-002 11571436 2029-05-14 Drug product 2023-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214120-002 12053482 2029-05-14 U-2950 2024-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214120-002 8846628 2030-06-03 U-2950 Drug product 2020-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214120-001 11571436 2029-05-14 Drug product 2023-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214120-001 12053482 2029-05-14 U-2950 2024-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214120-001 8846628 2030-06-03 U-2950 Drug product 2020-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214120-002 11571436 2029-05-14 Drug product 2023-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214120-002 12053482 2029-05-14 U-2950 2024-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214120-002 8846628 2030-06-03 U-2950 Drug product 2020-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214120-001 11571436 2029-05-14 Drug product 2023-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214120-001 12053482 2029-05-14 U-2950 2024-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214120-001 8846628 2030-06-03 U-2950 Drug product 2020-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214120-002 11571436 2029-05-14 Drug product 2023-02-10 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 108 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59572-730 ONUREG azacitidine Celgene Corporation NDA Current 59572-730 ONUREG azacitidine Celgene Corporation NDA Current 59572-730 ONUREG azacitidine Celgene Corporation NDA Current 59572-730 ONUREG azacitidine Celgene Corporation NDA Current 59572-730 ONUREG azacitidine Celgene Corporation NDA Current 59572-740 ONUREG azacitidine Celgene Corporation NDA Current 59572-740 ONUREG azacitidine Celgene Corporation NDA Current 59572-740 ONUREG azacitidine Celgene Corporation NDA Current 59572-740 ONUREG azacitidine Celgene Corporation NDA Current 59572-740 ONUREG azacitidine Celgene Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85677 SUPPL 2026-04-14 85673 SUPPL 2026-04-10 69839 SUPPL 2022-01-11 69830 SUPPL 2022-01-11 66059 ORIG 2021-02-02 64474 ORIG 2020-09-02 64467 ORIG 2020-09-01