Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011283
Company: DELCOR ASSET CORP
Company: DELCOR ASSET CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KENACORT | TRIAMCINOLONE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| KENACORT | TRIAMCINOLONE | 4MG | TABLET;ORAL | Discontinued | None | No | No |
| KENACORT | TRIAMCINOLONE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| KENACORT | TRIAMCINOLONE | 8MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/1958 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/07/1993 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 11/30/1987 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 08/21/1979 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 06/04/1979 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 07/17/1979 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 07/17/1979 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 07/19/1968 | SUPPL-3 |
Label is not available on this site. |