Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076096
Company: GENUS
Company: GENUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMCINONIDE | AMCINONIDE | 0.1% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
11/19/2002 | ORIG-1 | Approval |
Label is not available on this site. |
AMCINONIDE
OINTMENT;TOPICAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMCINONIDE | AMCINONIDE | 0.1% | OINTMENT;TOPICAL | Prescription | No | AB | 076096 | GENUS |
AMCINONIDE | AMCINONIDE | 0.1% | OINTMENT;TOPICAL | Prescription | No | AB | 076367 | TARO PHARM INDS |