Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205181
Company: TARO

Products on ANDA 205181

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205181

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2017	ORIG-1	Approval		STANDARD	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205181Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/205181Orig1_Approval_Pkg.pdf

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

BUTENAFINE 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
BUTENAFINE HYDROCHLORIDE	BUTENAFINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Over-the-counter	No	205181	TARO
LOTRIMIN ULTRA	BUTENAFINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Over-the-counter	Yes	021307	BAYER HEALTHCARE LLC