Home Applications 215383 Application 215383
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 WELIREG BELZUTIFAN TABLET;ORAL 40MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N215383-001 WELIREG BELZUTIFAN 40MG TABLET / ORAL RLD, RS 2021-08-13
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 N215383-001 9908845 2034-09-05 U-4565 Drug substance, Drug product 2021-09-09 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 N215383-001 RE49948 2034-09-05 U-4565 Drug substance, Drug product 2024-05-28 N215383-001 10335388 2036-04-14 U-4565 2026-07-08 N215383-001 12358870 2042-06-30 Drug product 2025-07-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 5 matching rows.
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 2026-09-14 22:38:34 2026-08 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 9908845 2034-09-05 U-4565 Drug substance, Drug product 2021-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 RE49948 2034-09-05 U-4565 Drug substance, Drug product 2024-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 10335388 2036-04-14 U-4565 2026-07-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-4565 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-4565 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 10335388 2036-04-14 U-4565 2026-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 96 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 WELIREG BELZUTIFAN Merck Sharp & Dohme LLC 13e15ee0-d679-4fa9-9430-e2e2170474da 2026-06-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 215383 application number: NDA215383 ndc (product): 0006-5331
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-5331 WELIREG belzutifan Merck Sharp & Dohme Corp. NDA Current 0006-5331 WELIREG belzutifan Merck Sharp & Dohme LLC NDA Current