Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020524
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MENTAX BUTENAFINE HYDROCHLORIDE 1% CREAM;TOPICAL Prescription None Yes 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
10/18/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020524Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/17/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/06/2001 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20524s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20524S5ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-524S005_Mentax.cfm
11/01/1999 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/31/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1997 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/25/1997 SUPPL-1 Efficacy-New Dosing Regimen

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/06/2001 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20524s5lbl.pdf

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