Home Applications 207997 Application 207997
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RYDAPT MIDOSTAURIN CAPSULE;ORAL 25MG 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 N207997-001 RYDAPT MIDOSTAURIN 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N207997-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207997-001 7973031 2028-10-09 U-2007 2017-05-23 N207997-001 8575146 2030-12-02 U-2008 2017-05-23
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 · 41 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 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207997-001 RYDAPT 25MG CAPSULE / ORAL AB RLD, RS 2017-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207997-001 RYDAPT 25MG CAPSULE / ORAL RLD, RS 2017-04-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 3 · 100 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 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207997-001 8222244 2022-10-29 U-2007 2017-05-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207997-001 7973031 2028-10-09 U-2007 2017-05-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207997-001 8222244 2022-10-29 U-2007 2017-05-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207997-001 7973031 2024-10-17 U-2007 2017-05-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207997-001 8222244 2022-10-29 U-2007 2017-05-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207997-001 7973031 2024-10-17 U-2007 2017-05-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207997-001 8222244 2022-10-29 U-2007 2017-05-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207997-001 7973031 2024-10-17 U-2007 2017-05-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207997-001 8575146 2030-12-02 U-2008 2017-05-23 74a2ff9319b5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 88 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 RYDAPT RYDAPT Novartis Pharmaceuticals Corporation 11fa3fc9-6776-49a6-b1c1-653f627c3e58 2026-06-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 207997 application number: NDA207997 ndc (product): 0078-0698
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0698 RYDAPT RYDAPT Novartis Pharmaceuticals Corporation NDA Current 0078-0698 RYDAPT RYDAPT Novartis Pharmaceuticals Corporation NDA Current 0078-0698 RYDAPT RYDAPT Novartis Pharmaceuticals Corporation NDA Current 0078-0698 RYDAPT RYDAPT Novartis Pharmaceuticals Corporation NDA Current 0078-0698 RYDAPT RYDAPT Novartis Pharmaceuticals Corporation NDA Current 0078-0698 RYDAPT RYDAPT Novartis Pharmaceuticals Corporation NDA Current 0078-0698 RYDAPT RYDAPT Novartis Pharmaceuticals Corporation NDA Current 0078-0698 RYDAPT RYDAPT Novartis Pharmaceuticals Corporation NDA Current