Drugs@FDA: FDA-Approved Drugs
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | CREAM;TOPICAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 08/31/1993 | 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 |
|---|---|---|---|---|---|
| 08/20/2009 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 11/04/2002 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/2001 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/24/2001 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/2001 | SUPPL-22 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 01/24/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/2000 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/23/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/23/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLOTRIMAZOLE
CREAM;TOPICAL; 1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | CREAM;TOPICAL | Prescription | No | AB | 078338 | FOUGERA PHARMS |
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | CREAM;TOPICAL | Prescription | No | AB | 090219 | GLENMARK PHARMS |
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | CREAM;TOPICAL | Prescription | No | AB | 072640 | TARO |