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 ALKEM LABS LTD
Abbreviated New Drug Application (ANDA): 213039
Company: ALKEM LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 05/06/2021 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
CLOBAZAM
SUSPENSION;ORAL; 2.5MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 213039 | ALKEM LABS LTD |
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 210039 | AMNEAL |
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 208819 | BIONPHARMA INC |
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 209796 | HETERO LABS LTD III |
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 209715 | HIKMA |
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 213110 | LANNETT CO INC |
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 210546 | LUPIN LTD |
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 211259 | MYLAN |
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 210569 | UPSHER SMITH LABS |
| CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 210746 | VISTAPHARM |
| ONFI | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | Yes | AB | 203993 | LUNDBECK PHARMS LLC |
منبع : www.accessdata.fda.gov
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