Home Applications 213973 Application 213973
Type NDA
Sponsor DECIPHERA PHARMACEUTICALS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QINLOCK RIPRETINIB TABLET;ORAL 150MG 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 N213973-001 QINLOCK RIPRETINIB 50MG TABLET / ORAL RLD, RS 2020-05-15
Orange Book patents# Current patent rows page 1 of 1 · 42 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213973-001 ODE-298 2027-05-15
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 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213973-001 QINLOCK 50MG TABLET / ORAL RLD, RS 2020-05-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 22 · 842 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 N213973-001 8188113 2030-07-27 Drug substance, Drug product 2020-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 RE48731 2032-06-07 U-3219 2021-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 8461179 2034-05-15 Drug substance, Drug product 2020-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 10966966 2040-08-12 U-3153 2021-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11266635 2040-08-12 U-3330 2022-03-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11344536 2040-08-12 U-3381 2022-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11426390 2040-08-12 U-3416 2022-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11433056 2040-08-12 U-3423 2022-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11529336 2040-08-12 U-3382 2023-01-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11534432 2040-08-12 U-3442 2023-01-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11576904 2040-08-12 U-3537 2023-03-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11813251 2040-08-12 U-3750 2023-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12023325 2040-08-12 U-3960 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12023326 2040-08-12 U-3959 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12023327 2040-08-12 U-3958 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12059410 2040-08-12 U-3153 2024-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12059411 2040-08-12 U-3971 2024-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12295944 2040-08-12 U-4183 2025-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12318373 2040-08-12 U-4191 2025-06-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11185535 2040-12-30 Drug product 2021-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11395818 2040-12-30 Drug product 2022-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11576903 2040-12-30 Drug product 2023-03-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11612591 2040-12-30 Drug product 2023-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11793795 2040-12-30 Drug product 2023-11-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11801237 2040-12-30 U-3219 Drug product 2023-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11844788 2040-12-30 Drug product 2024-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11850240 2040-12-30 Drug product 2024-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11850241 2040-12-30 Drug product 2024-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11896585 2040-12-30 Drug product 2024-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11903933 2040-12-30 Drug product 2024-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11911370 2040-12-30 Drug product 2024-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11918564 2040-12-30 Drug product 2024-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 11969415 2040-12-30 U-3219 2024-05-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12023328 2040-12-30 U-3957 2024-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12064422 2040-12-30 U-3219 2024-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12213967 2040-12-30 Drug product 2025-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12213968 2040-12-30 Drug product 2025-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12226406 2040-12-30 Drug product 2025-02-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12318374 2040-12-30 Drug product 2025-06-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213973-001 12708617 2040-12-30 U-3219 2026-08-26 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 2 of 2 · 74 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.
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73207-101 QINLOCK Ripretinib Deciphera Pharmaceuticals, LLC NDA Current 73207-101 QINLOCK Ripretinib Deciphera Pharmaceuticals, LLC NDA Current 73207-101 QINLOCK Ripretinib Deciphera Pharmaceuticals, LLC NDA Current 73207-101 QINLOCK Ripretinib Decipera Pharmaceuticals, LLC NDA Current 73207-101 QINLOCK Ripretinib Deciphera Pharmaceuticals, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82166 SUPPL 2025-05-08 82209 SUPPL 2025-05-06 75978 SUPPL 2023-10-27 75963 SUPPL 2023-10-27 73076 SUPPL 2023-01-04 73067 SUPPL 2023-01-03 72109 SUPPL 2022-09-19 72092 SUPPL 2022-09-16 67864 SUPPL 2021-06-22 67853 SUPPL 2021-06-22 63589 ORIG 2020-06-17 63093 ORIG 2020-05-19 63053 ORIG 2020-05-15