Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074260
Company: ACTAVIS ELIZABETH
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
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
02/15/2016 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.

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 073618 MAYNE PHARMA
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 078536 SUN PHARM INDS
SINEMET CARBIDOPA; LEVODOPA 10MG;100MG TABLET;ORAL Prescription Yes AB 017555 MERCK SHARP DOHME

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 073589 MAYNE PHARMA
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 078536 SUN PHARM INDS
SINEMET CARBIDOPA; LEVODOPA 25MG;100MG TABLET;ORAL Prescription Yes AB 017555 MERCK SHARP DOHME

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 073607 MAYNE PHARMA
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 078536 SUN PHARM INDS
SINEMET CARBIDOPA; LEVODOPA 25MG;250MG TABLET;ORAL Prescription Yes AB 017555 MERCK SHARP DOHME

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