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
CLOBAZAM از شرکت HETERO LABS LTD III
Abbreviated New Drug Application (ANDA): 209795
Company: HETERO LABS LTD III
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription |
AB |
No | No |
CLOBAZAM | CLOBAZAM | 20MG | 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 |
---|---|---|---|---|---|---|---|
10/22/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
CLOBAZAM
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 212714 | ALKEM LABS LTD |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 209718 | AMNEAL PHARMS CO |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 208825 | BIONPHARMA INC |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 209308 | BRECKENRIDGE |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 209795 | HETERO LABS LTD III |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 208785 | HIKMA |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 210545 | LUPIN LTD |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 211711 | MICRO LABS |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 213404 | MSN |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 209808 | PIRAMAL HLTHCARE UK |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 209687 | UPSHER SMITH LABS |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 211449 | ZYDUS PHARMS |
ONFI | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | Yes | AB | 202067 | LUNDBECK PHARMS LLC |
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 212714 | ALKEM LABS LTD |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 209718 | AMNEAL PHARMS CO |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 208825 | BIONPHARMA INC |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 209308 | BRECKENRIDGE |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 209795 | HETERO LABS LTD III |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 208785 | HIKMA |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 210545 | LUPIN LTD |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 211711 | MICRO LABS |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 213404 | MSN |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 209808 | PIRAMAL HLTHCARE UK |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 209687 | UPSHER SMITH LABS |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | No | AB | 211449 | ZYDUS PHARMS |
ONFI | CLOBAZAM | 20MG | TABLET;ORAL | Prescription | Yes | AB | 202067 | LUNDBECK PHARMS LLC |
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