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
CARBIDOPA AND LEVODOPA از شرکت ALEMBIC PHARMS LTD
Abbreviated New Drug Application (ANDA): 210341
Company: ALEMBIC PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/05/2019 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
CARBIDOPA AND LEVODOPA
TABLET, EXTENDED RELEASE;ORAL; 25MG;100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202323 | ACCORD HLTHCARE |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210341 | ALEMBIC PHARMS LTD |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076212 | APOTEX |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076521 | IMPAX LABS |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075091 | MYLAN |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214091 | SCIEGEN PHARMS INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077828 | SUN PHARM INDS |
TABLET, EXTENDED RELEASE;ORAL; 50MG;200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202323 | ACCORD HLTHCARE |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210341 | ALEMBIC PHARMS LTD |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076212 | APOTEX |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076521 | IMPAX LABS |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075091 | MYLAN |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214091 | SCIEGEN PHARMS INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077828 | SUN PHARM INDS |
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