Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076096
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMCINONIDE AMCINONIDE 0.1% OINTMENT;TOPICAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/19/2002 ORIG-1 Approval

Label is not available on this site.

AMCINONIDE

OINTMENT;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMCINONIDE AMCINONIDE 0.1% OINTMENT;TOPICAL Prescription No AB 076096 FOUGERA PHARMS
AMCINONIDE AMCINONIDE 0.1% OINTMENT;TOPICAL Prescription No AB 076367 TARO PHARM INDS

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