Drugs@FDA: FDA-Approved Drugs

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

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 PHARMS
LOTRIMIN ULTRA BUTENAFINE HYDROCHLORIDE 1% CREAM;TOPICAL Over-the-counter Yes 021307 BAYER HEALTHCARE LLC

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