Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078536
Company: SUN PHARM INDS
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
10/28/2008 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
07/10/2018 SUPPL-15 Labeling-Container/Carton Labels

Label is not available on this site.

02/06/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/05/2013 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/04/2010 SUPPL-3 Labeling-Package Insert

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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