Drugs@FDA: FDA-Approved Drugs
Company: BAYER HEALTHCARE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GYNE-LOTRIMIN | CLOTRIMAZOLE | 100MG | TABLET;VAGINAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
03/24/1976 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/03/1999 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/17/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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02/27/1997 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/08/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
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04/14/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
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06/23/1992 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/30/1990 | SUPPL-16 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
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06/18/1987 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/20/1986 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/16/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
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11/12/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
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08/05/1981 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/11/1980 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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09/23/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
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07/16/1979 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/23/1979 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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05/18/1978 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/15/1977 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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08/09/1977 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |