Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078338
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | CREAM;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
09/02/2008 | ORIG-1 | Approval |
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 |