Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018116
Company: ASTELLAS
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOCORT | AMCINONIDE | 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |
| CYCLOCORT | AMCINONIDE | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/18/1979 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 06/16/1999 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/24/1998 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/23/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/23/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/02/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/26/1986 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/09/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |