An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090324
Company: MYLAN

Products on ANDA 090324

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090324

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2009	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
02/02/2021	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
11/19/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/19/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090324

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

Top