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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021958
Company: KARO HLTHCARE

Products on NDA 021958

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAMISIL AT	TERBINAFINE	1%	GEL;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021958

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2006	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021958lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021958s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021958TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/24/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/20/2012	SUPPL-3	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021958s003ltr.pdf
01/06/2010	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021958s002ltr.pdf

Labels for NDA 021958

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021958lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

LAMISIL AT

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

GEL;TOPICAL; 1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LAMISIL AT	TERBINAFINE	1%	GEL;TOPICAL	Over-the-counter	Yes	021958	KARO HLTHCARE

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