Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020663
Company: MYLAN BERTEK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MENTAX BUTENAFINE HYDROCHLORIDE 1% CREAM; TOPICAL Prescription 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
12/31/1996 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020663ap.pdf

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