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
ALBENDAZOLE از شرکت CIPLA LTD
Abbreviated New Drug Application (ANDA): 210434
Company: CIPLA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBENDAZOLE | ALBENDAZOLE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/21/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210434Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/24/2020 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
ALBENDAZOLE
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALBENDAZOLE | ALBENDAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 208094 | ACTAVIS ELIZABETH |
| ALBENDAZOLE | ALBENDAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 210434 | CIPLA LTD |
| ALBENDAZOLE | ALBENDAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 211034 | DR REDDYS |
| ALBENDAZOLE | ALBENDAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 211117 | EDENBRIDGE PHARMS |
| ALBENDAZOLE | ALBENDAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 213435 | MSN |
| ALBENDAZOLE | ALBENDAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 210011 | STRIDES PHARMA |
| ALBENDAZOLE | ALBENDAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 208979 | ZYDUS PHARMS |
| ALBENZA | ALBENDAZOLE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 020666 | IMPAX LABS INC |
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