Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020749
Company: KARO HLTHCARE

Products on NDA 020749

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020749

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020749_lamisil_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2002	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/22/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/27/2001	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/30/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
03/27/2003	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20749slr004_lamisil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20749slr004ltr.pdf
05/13/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020749

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2003	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20749slr004_lamisil_lbl.pdf