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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213973
Company: DECIPHERA PHARMS

Products on NDA 213973

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QINLOCK	RIPRETINIB	50MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213973

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213973s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213973Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213973Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213973s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213973Orig1s007ltr.pdf
12/29/2022	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213973s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213973Orig1s004ltr.pdf
09/15/2022	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213973s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213973Orig1s003ltr.pdf
06/17/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213973s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213973Orig1s001ltr.pdf

Labels for NDA 213973

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213973s007lbl.pdf
12/29/2022	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213973s004lbl.pdf
09/15/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213973s003lbl.pdf
09/15/2022	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213973s003lbl.pdf
06/17/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213973s001lbl.pdf
05/15/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213973s000lbl.pdf

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