Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020846
Company: KARO HLTHCARE

Products on NDA 20846

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAMISIL	TERBINAFINE	1%	GEL;TOPICAL	Discontinued	None	No	No

Labels for NDA 020846

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/1999	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20846s001lbl.pdf
04/29/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20846lbl.pdf