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
CYTADREN از شرکت NOVARTIS
New Drug Application (NDA): 018202
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTADREN | AMINOGLUTETHIMIDE | 250MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/29/1980 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/07/2003 | SUPPL-21 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018202s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18202slr021ltr.pdf |
||
| 05/13/2002 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/2002 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/18/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/23/1995 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1992 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/14/1984 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/16/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1981 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/02/1981 | SUPPL-3 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/07/2003 | SUPPL-21 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018202s021lbl.pdf |
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