Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088169
Company: FOUGERA PHARMS INC
Company: FOUGERA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | 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 |
---|---|---|---|---|---|---|---|
12/16/1982 | 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 |
---|---|---|---|---|---|
03/07/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/13/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/09/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
FLUOCINOLONE ACETONIDE
CREAM;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% | CREAM;TOPICAL | Prescription | No | AT | 210747 | COSETTE |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 088169 | FOUGERA PHARMS INC |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 087104 | TARO |
SYNALAR | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | Yes | AT | 012787 | MEDIMETRIKS PHARMS |