Home Applications 203085 Application 203085
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STIVARGA REGORAFENIB TABLET;ORAL 40MG 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 N203085-001 STIVARGA REGORAFENIB 40MG TABLET / ORAL RLD, RS 2012-09-27
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203085-001 8680124 2030-06-02 U-1506 2014-04-21 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30
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 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 STIVARGA 40MG TABLET / ORAL AB RLD, RS 2012-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 STIVARGA 40MG TABLET / ORAL AB RLD, RS 2012-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 AB 1 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 AB 1 b8a1b40f171c…
Observed Orange Book patent history# Patent history page 1 of 5 · 182 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 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 d06236e962d9…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 47 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 Stivarga REGORAFENIB Bayer HealthCare Pharmaceuticals Inc. 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 2026-02-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 203085 application number: NDA203085 ndc (product): 50419-171
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-171 Stivarga regorafenib Bayer HealthCare Pharmaceuticals Inc. NDA Current