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
ACYCLOVIR از شرکت ACTAVIS ELIZABETH
Abbreviated New Drug Application (ANDA): 074870
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Discontinued |
None |
No | No |
| ACYCLOVIR | ACYCLOVIR | 800MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/05/1997 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074870_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/28/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/23/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/26/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
نظرات کاربران