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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020980
Company: KARO HLTHCARE

Products on NDA 020980

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020980

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/1999	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20980_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20980.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2019	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020980Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020980Orig1s012ltr.pdf
11/24/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
09/10/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/20/2012	SUPPL-9	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020980s009ltr.pdf
11/19/2009	SUPPL-7	Labeling		Label is not available on this site.
07/25/2007	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020980s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020980s005ltr.pdf
05/09/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
09/03/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/22/1999	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020980

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2019	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020980Orig1s012lbl.pdf
07/25/2007	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020980s005lbl.pdf

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

LAMISIL

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

CREAM;TOPICAL; 1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LAMISIL	TERBINAFINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Over-the-counter	Yes	020980	KARO HLTHCARE
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Over-the-counter	No	077511	TARO

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