اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CYCLOCORT از شرکت ASTELLAS
New Drug Application (NDA): 019729
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 |
|
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. |
منبع : www.accessdata.fda.gov
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