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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213433
Company: SUN PHARM

Products on NDA 213433

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WINLEVI	CLASCOTERONE	1%	CREAM;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213433

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213433s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213433Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213433Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2022	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213433Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213433Orig1s002ltr.pdf
08/19/2021	SUPPL-1			Label is not available on this site.

Labels for NDA 213433

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2022	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213433Orig1s002lbl.pdf
03/18/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213433Orig1s002lbl.pdf
03/18/2022	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213433Orig1s002lbl.pdf
08/26/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213433s000lbl.pdf

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