Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209030
Company: TELIGENT
Company: TELIGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | GEL;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 |
|---|---|---|---|---|---|---|---|
| 06/19/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUOCINONIDE
GEL;TOPICAL; 0.05%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | GEL;TOPICAL | Prescription | Yes | AB | 017373 | CNTY LINE PHARMS |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 072537 | COSETTE |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 072933 | FOUGERA PHARMS INC |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 074935 | TARO |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 209030 | TELIGENT |
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