Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206960
Company: TOLMAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE 2% CREAM;TOPICAL Prescription AB 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
04/10/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

NAFTIFINE HYDROCHLORIDE

CREAM;TOPICAL; 2%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE 2% CREAM;TOPICAL Prescription No AB 206901 TARO PHARMS
NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE 2% CREAM;TOPICAL Prescription No AB 206960 TOLMAR
NAFTIN NAFTIFINE HYDROCHLORIDE 2% CREAM;TOPICAL Prescription Yes AB 019599 SEBELA IRELAND LTD

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