Drugs@FDA: FDA-Approved Drugs
Company: MEDTECH PRODUCTS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MONISTAT 7 COMBINATION PACK | MICONAZOLE NITRATE | 2%,100MG | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
04/26/1993 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/10/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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10/28/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/10/2002 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/20/2000 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/04/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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03/26/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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03/21/1997 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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08/15/1996 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
MONISTAT 7 COMBINATION PACK
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM, SUPPOSITORY;TOPICAL, VAGINAL; 2%,100MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
MONISTAT 7 COMBINATION PACK | MICONAZOLE NITRATE | 2%,100MG | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | Over-the-counter | Yes | 020288 | MEDTECH PRODUCTS |