Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077511
Company: TARO
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
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.cfm
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.

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 GLAXOSMITHKLINE
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE 1% CREAM;TOPICAL Over-the-counter No 077511 TARO

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