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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212608
Company: BLUEPRINT MEDICINES

Products on NDA 212608

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AYVAKIT	AVAPRITINIB	100MG	TABLET;ORAL	Prescription	None	Yes	No
AYVAKIT	AVAPRITINIB	200MG	TABLET;ORAL	Prescription	None	Yes	No
AYVAKIT	AVAPRITINIB	300MG	TABLET;ORAL	Prescription	None	Yes	Yes
AYVAKIT	AVAPRITINIB	25MG	TABLET;ORAL	Prescription	None	Yes	No
AYVAKIT	AVAPRITINIB	50MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212608

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212608s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212608Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212608Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2023	SUPPL-13	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212608s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212608Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212608Orig1s013.pdf
03/09/2023	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212608s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212608Orig1s012ltr.pdf
06/16/2021	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212608Orig1s007ltr.pdf
06/16/2021	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212608Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/212608Orig1s006.pdf

Labels for NDA 212608

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2023	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212608s013lbl.pdf
03/09/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212608s012lbl.pdf
06/16/2021	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s007lbl.pdf
06/16/2021	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s006lbl.pdf
01/09/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212608s000lbl.pdf

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