Drugs@FDA: FDA-Approved Drugs
Company: P AND L
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | CREAM;VAGINAL | Over-the-counter | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 07/16/1993 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/10/2022 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/09/2015 | SUPPL-39 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/05/2015 | SUPPL-38 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/14/2015 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/14/2015 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/10/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1999 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/15/1999 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/15/1999 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/13/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/28/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/19/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/10/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
CLOTRIMAZOLE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM;VAGINAL; 1%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | CREAM;VAGINAL | Over-the-counter | No | 074165 | P AND L |
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | CREAM;VAGINAL | Over-the-counter | No | 072641 | TARO |