Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020663
Company: MYLAN BERTEK
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 |