Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040041
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
09/15/1994 | 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 |
---|---|---|---|---|---|
09/17/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
FLUOCINOLONE ACETONIDE
OINTMENT;TOPICAL; 0.025%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | OINTMENT;TOPICAL | Prescription | No | AT | 089524 | COSETTE |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | OINTMENT;TOPICAL | Prescription | No | AT | 088168 | FOUGERA PHARMS INC |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | OINTMENT;TOPICAL | Prescription | No | AT | 040041 | TARO |
SYNALAR | FLUOCINOLONE ACETONIDE | 0.025% | OINTMENT;TOPICAL | Prescription | Yes | AT | 013960 | MEDIMETRIKS PHARMS |