Home Applications 213721 Application 213721
Type NDA
Sponsor BLUEPRINT MEDICINES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GAVRETO PRALSETINIB CAPSULE;ORAL 100MG Yes No
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 N213721-001 GAVRETO PRALSETINIB 100MG CAPSULE / ORAL RLD, RS 2020-09-04
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 N213721-001 12539303 2039-04-03 U-2828 2026-03-04 N213721-001 12448366 2042-07-07 Drug substance 2026-02-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213721-001 ODE-318 2027-09-04 N213721-001 ODE-340 2027-12-01 N213721-001 ODE-341 2027-12-01
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.
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 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213721-001 GAVRETO 100MG CAPSULE / ORAL RLD, RS 2020-09-04 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 150 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 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 136 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-210 Gavreto Pralsetinib Genentech, Inc. NDA Current 50242-210 Gavreto Pralsetinib Genentech, Inc. NDA Current 50242-210 Gavreto Pralsetinib Genentech, Inc. NDA Current 50242-210 Gavreto Pralsetinib Genentech, Inc. NDA Current 72064-210 GAVRETO pralsetinib Blueprint Medicines Corporation NDA Current 72064-210 GAVRETO pralsetinib Blueprint Medicines Corporation NDA Current 72064-210 GAVRETO pralsetinib Blueprint Medicines Corporation NDA Current