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 MID ATLANTIC
Abbreviated New Drug Application (ANDA): 074738
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 04/28/1997 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/10/2009 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 01/24/2005 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/18/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/22/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/16/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/16/2001 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/06/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/26/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
ACYCLOVIR
SUSPENSION;ORAL; 200MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 074738 | ACTAVIS MID ATLANTIC |
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 077026 | AKORN |
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 212718 | HERITAGE PHARMS INC |
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 212252 | NOVITIUM PHARMA |
| ZOVIRAX | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 019909 | MYLAN |
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