Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088042
Company: CROWN LABS
Company: CROWN LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIDERM | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Prescription | AT | No | No |
| TRIDERM | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | AT | No | No |
| TRIDERM | TRIAMCINOLONE ACETONIDE | 0.5% | 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 |
|---|---|---|---|---|---|---|---|
| 03/19/1984 | 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 |
|---|---|---|---|---|---|
| 01/07/2015 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/14/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/10/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/05/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |
TRIDERM
CREAM;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% | CREAM;TOPICAL | Prescription | No | AT | 207651 | ALKEM LABS LTD |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AT | 208763 | CHARTWELL RX |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AT | 089798 | COSETTE PHARMS NC |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AT | 208848 | ENCUBE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AT | 085692 | FOUGERA PHARMS |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AT | 209535 | MACLEODS PHARMS LTD |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AT | 040671 | MICRO LABS |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AT | 086413 | PADAGIS US |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AT | 040039 | TARO |
| TRIDERM | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AT | 088042 | CROWN LABS |
CREAM;TOPICAL; 0.025%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 207651 | ALKEM LABS LTD |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 208763 | CHARTWELL RX |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 089797 | COSETTE PHARMS NC |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | Yes | AT | 085692 | FOUGERA PHARMS |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 209535 | MACLEODS PHARMS LTD |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 040671 | MICRO LABS |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 086413 | PADAGIS US |
| TRIDERM | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 088042 | CROWN LABS |
CREAM;TOPICAL; 0.5%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM;TOPICAL | Prescription | No | AT | 207651 | ALKEM LABS LTD |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM;TOPICAL | Prescription | No | AT | 208763 | CHARTWELL RX |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM;TOPICAL | Prescription | Yes | AT | 085692 | FOUGERA PHARMS |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM;TOPICAL | Prescription | No | AT | 209535 | MACLEODS PHARMS LTD |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM;TOPICAL | Prescription | No | AT | 086413 | PADAGIS US |
| TRIDERM | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM;TOPICAL | Prescription | No | AT | 088042 | CROWN LABS |