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, LEVODOPA AND ENTACAPONE از شرکت SUN PHARM
Abbreviated New Drug Application (ANDA): 079085
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/10/2012 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2014 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
CARBIDOPA, LEVODOPA AND ENTACAPONE
TABLET;ORAL; 25MG;200MG;100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET;ORAL | Prescription | No | AB | 079085 | SUN PHARM |
| STALEVO 100 | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |
TABLET;ORAL; 37.5MG;200MG;150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET;ORAL | Prescription | No | AB | 079085 | SUN PHARM |
| STALEVO 150 | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |
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