Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213212
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 12.5MG;200MG;50MG | TABLET;ORAL | Prescription | AB | No | No |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 18.75MG;200MG;75MG | TABLET;ORAL | Prescription | AB | No | No |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET;ORAL | Prescription | AB | No | No |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 31.25MG;200MG;125MG | TABLET;ORAL | Prescription | AB | No | No |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET;ORAL | Prescription | AB | No | No |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 50MG;200MG;200MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/25/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213212Orig1s000ltr.pdf |
CARBIDOPA, LEVODOPA AND ENTACAPONE
TABLET;ORAL; 12.5MG;200MG;50MG
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 | 12.5MG;200MG;50MG | TABLET;ORAL | Prescription | No | AB | 213212 | RISING |
| STALEVO 50 | CARBIDOPA; ENTACAPONE; LEVODOPA | 12.5MG;200MG;50MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |
TABLET;ORAL; 18.75MG;200MG;75MG
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 | 18.75MG;200MG;75MG | TABLET;ORAL | Prescription | No | AB | 213212 | RISING |
| STALEVO 75 | CARBIDOPA; ENTACAPONE; LEVODOPA | 18.75MG;200MG;75MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |
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 | 213212 | RISING |
| 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; 31.25MG;200MG;125MG
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 | 31.25MG;200MG;125MG | TABLET;ORAL | Prescription | No | AB | 213212 | RISING |
| STALEVO 125 | CARBIDOPA; ENTACAPONE; LEVODOPA | 31.25MG;200MG;125MG | 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 | 213212 | RISING |
| 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 |
TABLET;ORAL; 50MG;200MG;200MG
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 | 50MG;200MG;200MG | TABLET;ORAL | Prescription | No | AB | 213212 | RISING |
| STALEVO 200 | CARBIDOPA; ENTACAPONE; LEVODOPA | 50MG;200MG;200MG | TABLET;ORAL | Prescription | Yes | AB | 021485 | ORION PHARMA |