Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209913
Company: ENCUBE ETHICALS
Company: ENCUBE ETHICALS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
02/13/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUOCINOLONE ACETONIDE
SOLUTION;TOPICAL; 0.01%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | No | AT | 209596 | CHARTWELL RX |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | No | AT | 209913 | ENCUBE ETHICALS |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | No | AT | 088167 | FOUGERA PHARMS INC |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | No | AT | 206422 | LUPIN |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | No | AT | 089124 | TARO |
SYNALAR | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | Yes | AT | 015296 | MEDIMETRIKS PHARMS |