Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215039
Company: NOVARTIS

Products on NDA 215039

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIJOICE	ALPELISIB	50MG	TABLET;ORAL	Prescription	None	Yes	No
VIJOICE	ALPELISIB	125MG	TABLET;ORAL	Prescription	None	Yes	No
VIJOICE	ALPELISIB	200MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215039

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2022	ORIG-1	Approval		PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215039s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215039Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215039Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2022	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215039s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215039Orig1s001ltr.pdf

Labels for NDA 215039

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215039s001lbl.pdf
04/05/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215039s000lbledt.pdf