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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076212
Company: APOTEX

Products on ANDA 076212

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076212

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2004	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
11/17/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/30/2010	SUPPL-9	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076212

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
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
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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