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
ALBENZA از شرکت IMPAX LABS INC
New Drug Application (NDA): 020666
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBENZA | ALBENDAZOLE | 200MG | TABLET;ORAL | Prescription |
AB |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/11/1996 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020666Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/11/2019 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020666s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020666Orig1s012ltr.pdf |
||
| 10/31/2018 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020666Orig1s011ltr.pdf |
||
| 12/20/2017 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020666s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020666Orig1s010ltr.pdf |
||
| 06/11/2015 | SUPPL-9 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020666Orig1s009ltr.pdf |
||
| 10/20/2009 | SUPPL-6 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf |
||
| 10/20/2009 | SUPPL-5 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf |
||
| 08/20/2007 | SUPPL-4 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020666s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/11/2019 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020666s012lbl.pdf | |
| 10/31/2018 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf | |
| 10/31/2018 | SUPPL-11 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020666s011lbl.pdf | |
| 12/20/2017 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020666s010lbl.pdf | |
| 06/11/2015 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf | |
| 10/20/2009 | SUPPL-6 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf | |
| 10/20/2009 | SUPPL-5 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf | |
| 08/20/2007 | SUPPL-4 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf |
ALBENZA
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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