Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089129
Company: COSETTE PHARMS NC
Company: COSETTE PHARMS NC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | LOTION;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 |
|---|---|---|---|---|---|---|---|
| 08/14/1986 | 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 |
|---|---|---|---|---|---|
| 03/23/2000 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/23/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/29/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/03/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/05/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/03/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/21/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
TRIAMCINOLONE ACETONIDE
LOTION;TOPICAL; 0.1%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | LOTION;TOPICAL | Prescription | No | AT | 089129 | COSETTE PHARMS NC |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | LOTION;TOPICAL | Prescription | No | AT | 202374 | EPIC PHARMA LLC |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | LOTION;TOPICAL | Prescription | No | AT | 040467 | FOUGERA PHARMS |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | LOTION;TOPICAL | Prescription | No | AT | 040672 | MICRO LABS |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | LOTION;TOPICAL | Prescription | No | AT | 088451 | PHARMOBEDIENT |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | LOTION;TOPICAL | Prescription | No | AT | 213559 | QUAGEN |