Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076763
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOTRIMAZOLE | CLOTRIMAZOLE | 10MG | TROCHE/LOZENGE;ORAL | 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 |
---|---|---|---|---|---|---|---|
10/28/2005 | 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 |
---|---|---|---|---|---|
09/10/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
CLOTRIMAZOLE
TROCHE/LOZENGE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOTRIMAZOLE | CLOTRIMAZOLE | 10MG | TROCHE/LOZENGE;ORAL | Prescription | No | AB | 076387 | HIKMA |
CLOTRIMAZOLE | CLOTRIMAZOLE | 10MG | TROCHE/LOZENGE;ORAL | Prescription | No | AB | 076763 | PADAGIS US |
CLOTRIMAZOLE | CLOTRIMAZOLE | 10MG | TROCHE/LOZENGE;ORAL | Prescription | No | AB | 215641 | THINQ PHARM-CRO PVT |