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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079085
Company: SUN PHARM

Products on ANDA 079085

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079085

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.

Therapeutic Equivalents for ANDA 079085

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	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; 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

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