Home Applications 212576 Application 212576
Type NDA
Sponsor ASTEX PHARMACEUTICALS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 INQOVI DECITABINE;CEDAZURIDINE TABLET;ORAL 35MG;100MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N212576-001 INQOVI CEDAZURIDINE; DECITABINE 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212576-001 8618075 2028-10-16 U-2864 2020-08-05 N212576-001 8618075 2028-10-16 U-2867 2020-08-05 N212576-001 9567363 2028-10-16 Drug substance 2020-08-05 N212576-001 8268800 2030-08-22 U-2864 Drug substance 2020-08-05 N212576-001 8268800 2030-08-22 U-2865 Drug substance 2020-08-05 N212576-001 8268800 2030-08-22 U-2866 Drug substance 2020-08-05 N212576-001 8268800 2030-08-22 U-2867 Drug substance 2020-08-05 N212576-001 12195496 2040-10-07 Drug product 2025-02-07 N212576-001 11963971 2041-02-24 Drug product 2024-05-10 N212576-001 12239653 2041-02-24 U-2865 2025-03-27 N212576-001 12239653 2041-02-24 U-2866 2025-03-27
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212576-001 ODE-316 2027-07-07 N212576-001 I-990 2029-05-13
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 2026-08-18 06:07:40 2026-07 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 298 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N212576-001 8618075 2028-10-16 U-2864 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 8618075 2028-10-16 U-2867 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 9567363 2028-10-16 Drug substance 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 8268800 2030-08-22 U-2866 Drug substance 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 8268800 2030-08-22 U-2865 Drug substance 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 8268800 2030-08-22 U-2864 Drug substance 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 8268800 2030-08-22 U-2867 Drug substance 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 12195496 2040-10-07 Drug product 2025-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 11963971 2041-02-24 Drug product 2024-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 12239653 2041-02-24 U-2865 2025-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 12239653 2041-02-24 U-2866 2025-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212576-001 8618075 2028-10-16 U-2864 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 8618075 2028-10-16 U-2867 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 9567363 2028-10-16 Drug substance 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 8268800 2030-08-22 U-2866 Drug substance 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 8268800 2030-08-22 U-2865 Drug substance 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 8268800 2030-08-22 U-2864 Drug substance 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 8268800 2030-08-22 U-2867 Drug substance 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 12195496 2040-10-07 Drug product 2025-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 11963971 2041-02-24 Drug product 2024-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 12239653 2041-02-24 U-2865 2025-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 12239653 2041-02-24 U-2866 2025-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8618075 2028-10-16 U-2864 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8618075 2028-10-16 U-2867 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 9567363 2028-10-16 Drug substance 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8268800 2030-08-22 U-2866 Drug substance 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8268800 2030-08-22 U-2865 Drug substance 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8268800 2030-08-22 U-2864 Drug substance 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8268800 2030-08-22 U-2867 Drug substance 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 12195496 2040-10-07 Drug product 2025-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 11963971 2041-02-24 Drug product 2024-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 12239653 2041-02-24 U-2865 2025-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 12239653 2041-02-24 U-2866 2025-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212576-001 8618075 2028-10-16 U-2864 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 8618075 2028-10-16 U-2867 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 9567363 2028-10-16 Drug substance 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 8268800 2030-08-22 U-2866 Drug substance 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 8268800 2030-08-22 U-2865 Drug substance 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 8268800 2030-08-22 U-2864 Drug substance 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 8268800 2030-08-22 U-2867 Drug substance 2020-08-05 6a471c1ec25d…
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 INQOVI CEDAZURIDINE AND DECITABINE Taiho Pharmaceutical Co., Ltd. 91a0f80b-f865-4d06-a40d-4d148d99ee71 2026-05-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 212576 application number: NDA212576 ndc (product): 64842-0727
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 64842-0727 INQOVI CEDAZURIDINE and DECITABINE Taiho Pharmaceutical Co., Ltd. NDA Current 64842-0727 INQOVI CEDAZURIDINE and DECITABINE Taiho Pharmaceutical Co., Ltd. NDA Current 64842-0727 INQOVI CEDAZURIDINE and DECITABINE Taiho Pharmaceutical Co., Ltd. NDA Current 64842-0727 INQOVI CEDAZURIDINE and DECITABINE Taiho Pharmaceutical Co., Ltd. NDA Current 64842-0727 INQOVI CEDAZURIDINE and DECITABINE Taiho Pharmaceutical Co., Ltd. NDA Current 64842-0727 INQOVI CEDAZURIDINE and DECITABINE Taiho Pharmaceutical Co., Ltd. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85926 SUPPL 2026-05-18 85918 SUPPL 2026-05-15 70609 SUPPL 2022-03-25 70603 SUPPL 2022-03-25 64100 ORIG 2020-07-27 63821 ORIG 2020-07-08 63820 ORIG 2020-07-07