Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211758
Company: TELIGENT
Company: TELIGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOCINONIDE | FLUOCINONIDE | 0.1% | 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 |
---|---|---|---|---|---|---|---|
04/03/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUOCINONIDE
CREAM;TOPICAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 211111 | AMNEAL |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 208989 | CADILA |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 200735 | FOUGERA PHARMS INC |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 091282 | GLENMARK GENERICS |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 090256 | PERRIGO ISRAEL |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 200734 | TARO |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 211758 | TELIGENT |
VANOS | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB | 021758 | MEDICIS |
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