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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076712
Company: FOUGERA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERCONAZOLE TERCONAZOLE 0.4% CREAM;VAGINAL 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
02/18/2005 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/20/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

TERCONAZOLE

CREAM;VAGINAL; 0.4%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TERCONAZOLE TERCONAZOLE 0.4% CREAM;VAGINAL Prescription No AB 076712 FOUGERA PHARMS
TERCONAZOLE TERCONAZOLE 0.4% CREAM;VAGINAL Prescription No AB 076043 SUN PHARMA CANADA
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