Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210554
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
08/21/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUOCINONIDE
CREAM;TOPICAL; 0.05%
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 210554 | AMNEAL |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 073085 | COSETTE |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 073030 | FOUGERA PHARMS INC |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 071500 | TARO |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 072488 | TEVA |