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 ROCHE PALO
New Drug Application (NDA): 020460
Company: ROCHE PALO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTOVENE | GANCICLOVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE;ORAL | Discontinued |
None |
Yes | No |
| CYTOVENE | GANCICLOVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 12/22/1994 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 09/13/2002 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/17/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/21/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1997 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20460.pdf |
|
| 05/30/1997 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/27/1996 | SUPPL-6 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-5 | Efficacy-New Indication |
Label is not available on this site. |
||
| 12/30/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/20/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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