Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091550
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KETOCONAZOLE | KETOCONAZOLE | 2% | AEROSOL, FOAM;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 |
---|---|---|---|---|---|---|---|
08/25/2011 | ORIG-1 | Approval |
Label is not available on this site. |
KETOCONAZOLE
AEROSOL, FOAM;TOPICAL; 2%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KETOCONAZOLE | KETOCONAZOLE | 2% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB | 091550 | PADAGIS ISRAEL |
KETOCONAZOLE | KETOCONAZOLE | 2% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB | 213601 | XIROMED |