Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091282
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
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 |
---|---|---|---|---|---|---|---|
07/14/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091282Orig1s000ltr.pdf |
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 | 200735 | FOUGERA PHARMS INC |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 091282 | GLENMARK PHARMS LTD |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 200734 | TARO |
FLUOCINONIDE | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 208989 | ZYDUS LIFESCIENCES |
VANOS | FLUOCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB | 021758 | BAUSCH |