Application 213973

Type
NDA
Sponsor
DECIPHERA PHARMACEUTICALS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QINLOCKRIPRETINIBTABLET;ORAL150MGYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213973-001QINLOCKRIPRETINIB50MGTABLET / ORALRLD, RS2020-05-15

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213973-00181881132030-07-27Drug substance, Drug product2020-06-11
N213973-001RE487312032-06-07U-32192021-10-04
N213973-00184611792034-05-15Drug substance, Drug product2020-06-11
N213973-001109669662040-08-12U-31532021-05-03
N213973-001112666352040-08-12U-33302022-03-24
N213973-001113445362040-08-12U-33812022-06-17
N213973-001114263902040-08-12U-34162022-09-15
N213973-001114330562040-08-12U-34232022-09-22
N213973-001115293362040-08-12U-33822023-01-12
N213973-001115344322040-08-12U-34422023-01-12
N213973-001115769042040-08-12U-35372023-03-06
N213973-001118132512040-08-12U-37502023-11-29
N213973-001120233252040-08-12U-39602024-07-03
N213973-001120233262040-08-12U-39592024-07-03
N213973-001120233272040-08-12U-39582024-07-03
N213973-001120594102040-08-12U-31532024-08-13
N213973-001120594112040-08-12U-39712024-08-13
N213973-001122959442040-08-12U-41832025-05-20
N213973-001123183732040-08-12U-41912025-06-10
N213973-001111855352040-12-30Drug product2021-12-13
N213973-001113958182040-12-30Drug product2022-08-11
N213973-001115769032040-12-30Drug product2023-03-06
N213973-001116125912040-12-30Drug product2023-04-10
N213973-001117937952040-12-30Drug product2023-11-02
N213973-001118012372040-12-30U-3219Drug product2023-11-16
N213973-001118447882040-12-30Drug product2024-01-08
N213973-001118502402040-12-30Drug product2024-01-08
N213973-001118502412040-12-30Drug product2024-01-08
N213973-001118965852040-12-30Drug product2024-02-27
N213973-001119039332040-12-30Drug product2024-02-27
N213973-001119113702040-12-30Drug product2024-03-13
N213973-001119185642040-12-30Drug product2024-03-13
N213973-001119694152040-12-30U-32192024-05-08
N213973-001120233282040-12-30U-39572024-07-03
N213973-001120644222040-12-30U-32192024-08-20
N213973-001122139672040-12-30Drug product2025-02-07
N213973-001122139682040-12-30Drug product2025-02-07
N213973-001122264062040-12-30Drug product2025-02-20
N213973-001123183742040-12-30Drug product2025-06-10
N213973-001127086172040-12-30U-32192026-08-26
N213973-001119694142041-02-08U-38972024-05-08
N213973-001117795722042-10-06U-37142023-11-02

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N213973-001ODE-2982027-05-15

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-1584e616aacf4f…
2026-08-18 06:07:402026-07N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213973-001QINLOCK50MGTABLET / ORALRLD, RS2020-05-15a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 22 · 842 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N213973-00181881132030-07-27Drug substance, Drug product2020-06-1184e616aacf4f…
2026-09-14 22:38:342026-08N213973-001RE487312032-06-07U-32192021-10-0484e616aacf4f…
2026-09-14 22:38:342026-08N213973-00184611792034-05-15Drug substance, Drug product2020-06-1184e616aacf4f…
2026-09-14 22:38:342026-08N213973-001109669662040-08-12U-31532021-05-0384e616aacf4f…
2026-09-14 22:38:342026-08N213973-001112666352040-08-12U-33302022-03-2484e616aacf4f…
2026-09-14 22:38:342026-08N213973-001113445362040-08-12U-33812022-06-1784e616aacf4f…
2026-09-14 22:38:342026-08N213973-001114263902040-08-12U-34162022-09-1584e616aacf4f…
2026-09-14 22:38:342026-08N213973-001114330562040-08-12U-34232022-09-2284e616aacf4f…
2026-09-14 22:38:342026-08N213973-001115293362040-08-12U-33822023-01-1284e616aacf4f…
2026-09-14 22:38:342026-08N213973-001115344322040-08-12U-34422023-01-1284e616aacf4f…
2026-09-14 22:38:342026-08N213973-001115769042040-08-12U-35372023-03-0684e616aacf4f…
2026-09-14 22:38:342026-08N213973-001118132512040-08-12U-37502023-11-2984e616aacf4f…
2026-09-14 22:38:342026-08N213973-001120233252040-08-12U-39602024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N213973-001120233262040-08-12U-39592024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N213973-001120233272040-08-12U-39582024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N213973-001120594102040-08-12U-31532024-08-1384e616aacf4f…
2026-09-14 22:38:342026-08N213973-001120594112040-08-12U-39712024-08-1384e616aacf4f…
2026-09-14 22:38:342026-08N213973-001122959442040-08-12U-41832025-05-2084e616aacf4f…
2026-09-14 22:38:342026-08N213973-001123183732040-08-12U-41912025-06-1084e616aacf4f…
2026-09-14 22:38:342026-08N213973-001111855352040-12-30Drug product2021-12-1384e616aacf4f…
2026-09-14 22:38:342026-08N213973-001113958182040-12-30Drug product2022-08-1184e616aacf4f…
2026-09-14 22:38:342026-08N213973-001115769032040-12-30Drug product2023-03-0684e616aacf4f…
2026-09-14 22:38:342026-08N213973-001116125912040-12-30Drug product2023-04-1084e616aacf4f…
2026-09-14 22:38:342026-08N213973-001117937952040-12-30Drug product2023-11-0284e616aacf4f…
2026-09-14 22:38:342026-08N213973-001118012372040-12-30U-3219Drug product2023-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N213973-001118447882040-12-30Drug product2024-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N213973-001118502402040-12-30Drug product2024-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N213973-001118502412040-12-30Drug product2024-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N213973-001118965852040-12-30Drug product2024-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N213973-001119039332040-12-30Drug product2024-02-2784e616aacf4f…
2026-09-14 22:38:342026-08N213973-001119113702040-12-30Drug product2024-03-1384e616aacf4f…
2026-09-14 22:38:342026-08N213973-001119185642040-12-30Drug product2024-03-1384e616aacf4f…
2026-09-14 22:38:342026-08N213973-001119694152040-12-30U-32192024-05-0884e616aacf4f…
2026-09-14 22:38:342026-08N213973-001120233282040-12-30U-39572024-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N213973-001120644222040-12-30U-32192024-08-2084e616aacf4f…
2026-09-14 22:38:342026-08N213973-001122139672040-12-30Drug product2025-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N213973-001122139682040-12-30Drug product2025-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N213973-001122264062040-12-30Drug product2025-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N213973-001123183742040-12-30Drug product2025-06-1084e616aacf4f…
2026-09-14 22:38:342026-08N213973-001127086172040-12-30U-32192026-08-2684e616aacf4f…

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213973-001ODE-2982027-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N213973-001NCE2025-05-155aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N213973-001ODE-2982027-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N213973-001NCE2025-05-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N213973-001ODE-2982027-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N213973-001NCE2025-05-15c0c555d07b60…
2020-11-12 02:37 UTC2020-11N213973-001ODE-2982027-05-15c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N213973-001NCE2025-05-156a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N213973-001ODE-2982027-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N213973-001NCE2025-05-151c564ffb4f44…
2024-02-18 07:12 UTC2024-02N213973-001ODE-2982027-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N213973-001NCE2025-05-15ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N213973-001ODE-2982027-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N213973-001NCE2025-05-15a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N213973-001ODE-2982027-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N213973-001NCE2025-05-159b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N213973-001ODE-2982027-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N213973-001NCE2025-05-15a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N213973-001ODE-2982027-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N213973-001NCE2025-05-153f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N213973-001ODE-2982027-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N213973-001NCE2025-05-15053a50430f4f…
2023-05-13 08:27 UTC2023-05N213973-001ODE-2982027-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N213973-001NCE2025-05-153bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N213973-001ODE-2982027-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N213973-001NCE2025-05-153a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N213973-001ODE-2982027-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N213973-001NCE2025-05-15f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N213973-001ODE-2982027-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N213973-001NCE2025-05-15e64feba35796…
2022-09-29 23:25 UTC2022-09N213973-001ODE-2982027-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N213973-001NCE2025-05-15cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N213973-001ODE-2982027-05-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213973-001ODE-2982027-05-15a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QINLOCKRIPRETINIBDeciphera Pharmaceuticals, LLC9f18e462-03dd-4296-a02a-a0577e3ee78d2025-05-12Warnings, Adverse reactionsExact 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
73207-101QINLOCKRipretinibDeciphera Pharmaceuticals, LLCNDACurrent
73207-101QINLOCKRipretinibDeciphera Pharmaceuticals, LLCNDACurrent
73207-101QINLOCKRipretinibDeciphera Pharmaceuticals, LLCNDACurrent
73207-101QINLOCKRipretinibDecipera Pharmaceuticals, LLCNDACurrent
73207-101QINLOCKRipretinibDeciphera Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82166SUPPL 2025-05-08
82209SUPPL 2025-05-06
75978SUPPL 2023-10-27
75963SUPPL 2023-10-27
73076SUPPL2023-01-04
73067SUPPL2023-01-03
72109SUPPL2022-09-19
72092SUPPL2022-09-16
67864SUPPL2021-06-22
67853SUPPL2021-06-22
63589ORIG2020-06-17
63093ORIG2020-05-19
63053ORIG2020-05-15