Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070730
Company: SUN PHARMA CANADA
Company: SUN PHARMA CANADA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | PASTE;DENTAL | Prescription | AT | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/01/1986 | 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 |
|---|---|---|---|---|---|
| 01/27/2011 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/08/2006 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/22/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/29/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/07/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/24/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
TRIAMCINOLONE ACETONIDE
PASTE;DENTAL; 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% | PASTE;DENTAL | Prescription | No | AT | 205592 | COSETTE PHARMS NC |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | PASTE;DENTAL | Prescription | No | AT | 214582 | QUAGEN |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | PASTE;DENTAL | Prescription | No | AT | 040771 | RISING |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | PASTE;DENTAL | Prescription | No | AT | 070730 | SUN PHARMA CANADA |