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
CARBAMAZEPINE از شرکت UNIQUE PHARM
Abbreviated New Drug Application (ANDA): 211623
Company: UNIQUE PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 04/24/2020 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
CARBAMAZEPINE
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
| TEGRETOL-XR | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |
TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
| TEGRETOL-XR | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |
TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
| TEGRETOL-XR | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |
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