Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213212
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

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