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| GYNE-LOTRIMIN | CLOTRIMAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;VAGINAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/08/1978 | 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 |
|---|---|---|---|---|---|
| 04/12/2010 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018052Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018052s032ltr.pdf | |
| 01/16/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/2001 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/01/2000 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/20/2000 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/11/1998 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/26/1993 | SUPPL-24 | Efficacy-New Indication |
Label is not available on this site. |
||
| 04/15/1993 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/08/1992 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/21/1993 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/12/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/14/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/22/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/04/1988 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1990 | SUPPL-12 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
||
| 06/18/1987 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1985 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/17/1981 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/1981 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/27/1981 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/03/1980 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/27/1979 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/12/2010 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018052Orig1s032lbl.pdf |