Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018592
Company: PERSONAL PRODS
Company: PERSONAL PRODS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MONISTAT 5 | MICONAZOLE NITRATE | 100MG | TAMPON;VAGINAL | Discontinued | 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 |
---|---|---|---|---|---|---|---|
10/27/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
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