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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208201
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE 2% GEL;TOPICAL Discontinued 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
04/10/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208201Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/12/2021 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

10/28/2019 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

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