Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089124
Company: TARO
Company: TARO
| 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 |
|---|---|---|---|---|---|---|---|
| 09/11/1985 | 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 |
|---|---|---|---|---|---|
| 07/31/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/29/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/02/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/18/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/03/1990 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/07/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1986 | SUPPL-2 | Manufacturing (CMC) |
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 |