Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215393
Company: PADAGIS ISRAEL

Products on ANDA 215393

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAZAROTENE	TAZAROTENE	0.045%	LOTION;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215393

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215393Orig1s000ltr.pdf