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 KENTON
Abbreviated New Drug Application (ANDA): 075090
Company: KENTON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/26/1999 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75090ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/08/2016 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/06/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/04/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
ACYCLOVIR
CAPSULE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 075677 | APOTEX |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 204313 | CADILA |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 201445 | CADILA PHARMS LTD |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 206261 | CARLSBAD TECHNOLOGY |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 074889 | HERITAGE PHARMS INC |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 075090 | KENTON |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 074578 | TEVA |
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Prescription | No | AB | 212173 | YILING |
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