Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019729
Company: ASTELLAS
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOCORT | AMCINONIDE | 0.1% | LOTION;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 |
|---|---|---|---|---|---|---|---|
| 06/13/1988 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19729_Cyclocort.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/19/2001 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/23/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1991 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/30/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/13/1988 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |