Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 021124
Company: GLAXOSMITHKLINE CONS

Products on NDA 021124

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021124

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2000	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21124lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21124ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-124_TerbinafineLamisil.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2018	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021124Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021124Orig1s016ltr.pdf
07/18/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
11/13/2013	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021124Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021124Orig1s013ltr.pdf
03/20/2012	SUPPL-11	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021124s011ltr.pdf
02/12/2010	SUPPL-9	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021124s009ltr.pdf
06/15/2009	SUPPL-8	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021124s008ltr.pdf
07/25/2008	SUPPL-7	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021124s007ltr.pdf
07/25/2002	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/08/2002	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/11/2002	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/09/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 021124

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
10/18/2018	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021124Orig1s016lbl.pdf
11/13/2013	SUPPL-13	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021124Orig1s013lbl.pdf
03/17/2000	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21124lbl.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.

SOLUTION;TOPICAL; 1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LAMISIL AT	TERBINAFINE HYDROCHLORIDE	1%	SOLUTION;TOPICAL	Over-the-counter	Yes	021124	GLAXOSMITHKLINE CONS

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

SPRAY;TOPICAL; 1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LAMISIL AT	TERBINAFINE HYDROCHLORIDE	1%	SPRAY;TOPICAL	Over-the-counter	Yes	021124	GLAXOSMITHKLINE CONS