Drugs@FDA: FDA-Approved Drugs
Company: INSIGHT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MONISTAT-DERM | MICONAZOLE NITRATE | 2% | CREAM;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/08/1974 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 02/11/2014 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/2014 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/27/2014 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/02/2014 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/20/2001 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/22/2001 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/12/1998 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/09/1990 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/17/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 09/17/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1986 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 06/24/1985 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1985 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/29/1984 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/02/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/19/1982 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/1981 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 04/28/1980 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/16/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 04/21/1977 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1975 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |