Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089526
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | CREAM;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 |
---|---|---|---|---|---|---|---|
07/26/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/25/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/25/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
FLUOCINOLONE ACETONIDE
CREAM;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% | CREAM;TOPICAL | Prescription | No | AT | 089526 | COSETTE |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | CREAM;TOPICAL | Prescription | No | AT | 088170 | FOUGERA PHARMS INC |
SYNALAR | FLUOCINOLONE ACETONIDE | 0.01% | CREAM;TOPICAL | Prescription | Yes | AT | 012787 | MEDIMETRIKS PHARMS |