Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083015
Company: ASTELLAS
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARISTOCORT | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM;TOPICAL | Discontinued | None | Yes | No |
| ARISTOCORT A | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/26/1972 | 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 |
|---|---|---|---|---|---|
| 10/08/1998 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/08/1998 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/08/1998 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1997 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/14/1995 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1992 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/16/1987 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/16/1987 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/28/1983 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |