Drugs@FDA: FDA-Approved Drugs
Company: MEDTECH PRODUCTS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MONISTAT 7 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY;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 |
---|---|---|---|---|---|---|---|
03/15/1982 | 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-24 | Manufacturing (CMC) |
Label is not available on this site. |
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03/26/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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10/08/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
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06/03/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
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02/15/1991 | SUPPL-11 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
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09/11/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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09/04/1985 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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06/24/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/24/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/27/1983 | SUPPL-5 | Labeling |
Label is not available on this site. |
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06/02/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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09/20/1982 | SUPPL-3 | Labeling |
Label is not available on this site. |
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05/13/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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04/19/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
MONISTAT 7
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUPPOSITORY;VAGINAL; 100MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
MICONAZOLE NITRATE | MICONAZOLE NITRATE | 100MG | SUPPOSITORY;VAGINAL | Over-the-counter | No | 073507 | COSETTE |
MONISTAT 7 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY;VAGINAL | Over-the-counter | Yes | 018520 | MEDTECH PRODUCTS |