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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213973-001	8188113	2030-07-27		Drug substance, Drug product	2020-06-11
N213973-001	RE48731	2032-06-07	U-3219		2021-10-04
N213973-001	8461179	2034-05-15		Drug substance, Drug product	2020-06-11
N213973-001	10966966	2040-08-12	U-3153		2021-05-03
N213973-001	11266635	2040-08-12	U-3330		2022-03-24
N213973-001	11344536	2040-08-12	U-3381		2022-06-17
N213973-001	11426390	2040-08-12	U-3416		2022-09-15
N213973-001	11433056	2040-08-12	U-3423		2022-09-22
N213973-001	11529336	2040-08-12	U-3382		2023-01-12
N213973-001	11534432	2040-08-12	U-3442		2023-01-12
N213973-001	11576904	2040-08-12	U-3537		2023-03-06
N213973-001	11813251	2040-08-12	U-3750		2023-11-29
N213973-001	12023325	2040-08-12	U-3960		2024-07-03
N213973-001	12023326	2040-08-12	U-3959		2024-07-03
N213973-001	12023327	2040-08-12	U-3958		2024-07-03
N213973-001	12059410	2040-08-12	U-3153		2024-08-13
N213973-001	12059411	2040-08-12	U-3971		2024-08-13
N213973-001	12295944	2040-08-12	U-4183		2025-05-20
N213973-001	12318373	2040-08-12	U-4191		2025-06-10
N213973-001	11185535	2040-12-30		Drug product	2021-12-13
N213973-001	11395818	2040-12-30		Drug product	2022-08-11
N213973-001	11576903	2040-12-30		Drug product	2023-03-06
N213973-001	11612591	2040-12-30		Drug product	2023-04-10
N213973-001	11793795	2040-12-30		Drug product	2023-11-02
N213973-001	11801237	2040-12-30	U-3219	Drug product	2023-11-16
N213973-001	11844788	2040-12-30		Drug product	2024-01-08
N213973-001	11850240	2040-12-30		Drug product	2024-01-08
N213973-001	11850241	2040-12-30		Drug product	2024-01-08
N213973-001	11896585	2040-12-30		Drug product	2024-02-27
N213973-001	11903933	2040-12-30		Drug product	2024-02-27
N213973-001	11911370	2040-12-30		Drug product	2024-03-13
N213973-001	11918564	2040-12-30		Drug product	2024-03-13
N213973-001	11969415	2040-12-30	U-3219		2024-05-08
N213973-001	12023328	2040-12-30	U-3957		2024-07-03
N213973-001	12064422	2040-12-30	U-3219		2024-08-20
N213973-001	12213967	2040-12-30		Drug product	2025-02-07
N213973-001	12213968	2040-12-30		Drug product	2025-02-07
N213973-001	12226406	2040-12-30		Drug product	2025-02-20
N213973-001	12318374	2040-12-30		Drug product	2025-06-10
N213973-001	12708617	2040-12-30	U-3219		2026-08-26
N213973-001	11969414	2041-02-08	U-3897		2024-05-08
N213973-001	11779572	2042-10-06	U-3714		2023-11-02

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	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 22 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
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213973-001	11969414	2041-02-08	U-3897		2024-05-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213973-001	11779572	2042-10-06	U-3714		2023-11-02	`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N213973-001	ODE-298	2027-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213973-001	ODE-298	2027-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213973-001	ODE-298	2027-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213973-001	NCE	2025-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213973-001	ODE-298	2027-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213973-001	NCE	2025-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213973-001	ODE-298	2027-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213973-001	NCE	2025-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213973-001	ODE-298	2027-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213973-001	NCE	2025-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213973-001	ODE-298	2027-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213973-001	NCE	2025-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213973-001	ODE-298	2027-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213973-001	NCE	2025-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213973-001	ODE-298	2027-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213973-001	NCE	2025-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213973-001	ODE-298	2027-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213973-001	NCE	2025-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213973-001	ODE-298	2027-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213973-001	NCE	2025-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213973-001	ODE-298	2027-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213973-001	NCE	2025-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213973-001	ODE-298	2027-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213973-001	NCE	2025-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213973-001	ODE-298	2027-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213973-001	NCE	2025-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213973-001	ODE-298	2027-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213973-001	NCE	2025-05-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213973-001	ODE-298	2027-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213973-001	NCE	2025-05-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213973-001	ODE-298	2027-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213973-001	NCE	2025-05-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213973-001	ODE-298	2027-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213973-001	NCE	2025-05-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213973-001	ODE-298	2027-05-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213973-001	NCE	2025-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213973-001	ODE-298	2027-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213973-001	NCE	2025-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213973-001	ODE-298	2027-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213973-001	NCE	2025-05-15	`87673890dc5c…`

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
QINLOCK	RIPRETINIB	Deciphera Pharmaceuticals, LLC	9f18e462-03dd-4296-a02a-a0577e3ee78d	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213973 application number: NDA213973 ndc (product): 73207-101

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