Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075953
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERCONAZOLE TERCONAZOLE 0.8% CREAM;VAGINAL Prescription BX 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
04/06/2004 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075953_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/25/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

08/25/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

TERCONAZOLE

There are no Therapeutic Equivalents.

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