Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077511
Company: SUN PHARMA CANADA

Products on ANDA 077511

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077511

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2007	ORIG-1	Approval			Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/077511_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/22/2014	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.

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

TERBINAFINE HYDROCHLORIDE

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	SUN PHARMA CANADA