Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080750
Company: ASTELLAS
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARISTOCORT | TRIAMCINOLONE ACETONIDE | 0.1% | OINTMENT;TOPICAL | Discontinued | None | No | No |
| ARISTOCORT A | TRIAMCINOLONE ACETONIDE | 0.1% | OINTMENT;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 |
|---|---|---|---|---|---|---|---|
| 04/26/1972 | 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 |
|---|---|---|---|---|---|
| 07/16/1997 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/14/1995 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/13/1989 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 10/13/1989 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/13/1989 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/13/1989 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/30/1983 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1982 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1982 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1982 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1982 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |