Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

Products on NDA 020846

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020846

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20846lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20846ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020846.pdf

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20846s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20846s1ltr.pdf

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