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): 018498
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOCORT | AMCINONIDE | 0.1% | OINTMENT;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 |
|---|---|---|---|---|---|---|---|
| 11/13/1981 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/11/1999 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/04/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/2002 | SUPPL-8 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18498s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18498slr008ltr.pdf |
||
| 08/09/1995 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/29/1991 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/26/1986 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/09/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1982 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/03/2002 | SUPPL-8 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18498s8lbl.pdf |
نظرات کاربران