Drugs@FDA: FDA-Approved Drugs
Company: BAYER HEALTHCARE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYCELEX-7 | CLOTRIMAZOLE | 100MG | TABLET;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 |
---|---|---|---|---|---|---|---|
02/27/1979 | 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 |
---|---|---|---|---|---|
09/07/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/10/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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05/24/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
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10/08/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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02/22/1993 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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12/26/1991 | SUPPL-9 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
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11/15/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
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06/03/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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01/28/1982 | SUPPL-5 | Labeling |
Label is not available on this site. |
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01/09/1981 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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08/05/1980 | SUPPL-1 | Labeling |
Label is not available on this site. |