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
CYTOVENE از شرکت CHEPLAPHARM
New Drug Application (NDA): 019661
Company: CHEPLAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTOVENE | GANCICLOVIR SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/1989 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/20/2020 | SUPPL-38 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019661Orig1s038ltr.pdf |
|
| 08/06/2018 | SUPPL-37 | Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019661s037lbl.pdf |
||
| 07/03/2017 | SUPPL-36 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019661s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019661Orig1s036ltr.pdf |
||
| 03/17/2016 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/2013 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/2006 | SUPPL-30 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019661s030ltr.pdf |
||
| 10/25/2002 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/23/2002 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/2002 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/2000 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/2000 | SUPPL-25 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/01/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1997 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/23/1997 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/08/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/08/1996 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/1995 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/1995 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/20/1995 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/13/1994 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/1992 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1993 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1992 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/19/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1992 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/09/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/06/2018 | SUPPL-37 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019661s037lbl.pdf | |
| 08/06/2018 | SUPPL-37 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019661s037lbl.pdf | |
| 07/03/2017 | SUPPL-36 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019661s036lbl.pdf | |
| 01/31/2006 | SUPPL-30 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf |
نظرات کاربران