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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074260
Company: ACTAVIS ELIZABETH

Products on ANDA 074260

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET;ORAL	Prescription	AB	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET;ORAL	Prescription	AB	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074260

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/03/1993	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
02/04/2021	SUPPL-55	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/15/2016	SUPPL-44	Labeling-Package Insert		Label is not available on this site.
11/04/2014	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
10/29/2009	SUPPL-32	Labeling		Label is not available on this site.
06/19/2007	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
11/16/2001	SUPPL-9	Labeling		Label is not available on this site.
11/02/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/11/2000	SUPPL-7	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
03/20/2000	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
03/20/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
04/15/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/18/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/21/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/21/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074260

CARBIDOPA AND LEVODOPA

TABLET;ORAL; 10MG;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	10MG;100MG	TABLET;ORAL	Prescription	No	AB	074260	ACTAVIS ELIZABETH
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET;ORAL	Prescription	No	AB	077120	APOTEX INC
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET;ORAL	Prescription	No	AB	216537	AUROBINDO PHARMA LTD
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET;ORAL	Prescription	No	AB	073618	DR REDDYS LABS SA
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET;ORAL	Prescription	No	AB	090324	MYLAN
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET;ORAL	Prescription	No	AB	216505	RUBICON
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET;ORAL	Prescription	No	AB	214092	SCIEGEN PHARMS INC
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET;ORAL	Prescription	No	AB	078536	SUN PHARM INDS
SINEMET	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET;ORAL	Prescription	Yes	AB	017555	ORGANON

TABLET;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;ORAL	Prescription	No	AB	074260	ACTAVIS ELIZABETH
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET;ORAL	Prescription	No	AB	077120	APOTEX INC
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET;ORAL	Prescription	No	AB	216537	AUROBINDO PHARMA LTD
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET;ORAL	Prescription	No	AB	073589	DR REDDYS LABS SA
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET;ORAL	Prescription	No	AB	090324	MYLAN
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET;ORAL	Prescription	No	AB	216505	RUBICON
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET;ORAL	Prescription	No	AB	214092	SCIEGEN PHARMS INC
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET;ORAL	Prescription	No	AB	078536	SUN PHARM INDS
SINEMET	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET;ORAL	Prescription	Yes	AB	017555	ORGANON

TABLET;ORAL; 25MG;250MG
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;250MG	TABLET;ORAL	Prescription	No	AB	074260	ACTAVIS ELIZABETH
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET;ORAL	Prescription	No	AB	077120	APOTEX INC
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET;ORAL	Prescription	No	AB	216537	AUROBINDO PHARMA LTD
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET;ORAL	Prescription	No	AB	073607	DR REDDYS LABS SA
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET;ORAL	Prescription	No	AB	090324	MYLAN
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET;ORAL	Prescription	No	AB	216505	RUBICON
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET;ORAL	Prescription	No	AB	214092	SCIEGEN PHARMS INC
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET;ORAL	Prescription	No	AB	078536	SUN PHARM INDS
SINEMET	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET;ORAL	Prescription	Yes	AB	017555	ORGANON

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