Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020524
Company: MYLAN

Products on NDA 20524

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MENTAX	BUTENAFINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Discontinued	None	Yes	No

Labels for NDA 020524

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2001	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20524s5lbl.pdf