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 APOTEX INC
Abbreviated New Drug Application (ANDA): 077309
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription |
AB |
No | No |
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 09/29/2005 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077309ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/28/2006 | SUPPL-1 | Labeling |
Label is not available on this site. |
ACYCLOVIR
TABLET;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription | No | AB | 077309 | APOTEX INC |
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription | No | AB | 202168 | CADILA PHARMS LTD |
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription | No | AB | 075382 | CARLSBAD |
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription | No | AB | 074946 | DAVA PHARMS INC |
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription | No | AB | 074891 | HERITAGE PHARMS INC |
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription | No | AB | 203834 | HETERO LABS LTD V |
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription | No | AB | 209366 | SQUARE PHARMS LTD |
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription | No | AB | 074556 | TEVA |
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription | No | AB | 210401 | YILING |
| ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Prescription | No | AB | 204314 | ZYDUS PHARMS |
TABLET;ORAL; 800MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 077309 | APOTEX INC |
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 202168 | CADILA PHARMS LTD |
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 075382 | CARLSBAD |
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 074946 | DAVA PHARMS INC |
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 074891 | HERITAGE PHARMS INC |
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 203834 | HETERO LABS LTD V |
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 209366 | SQUARE PHARMS LTD |
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 074556 | TEVA |
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 210401 | YILING |
| ACYCLOVIR | ACYCLOVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 204314 | ZYDUS PHARMS |
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