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CARBIDOPA AND LEVODOPA از شرکت APOTEX INC

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CARBIDOPA AND LEVODOPA از شرکت APOTEX INC

Abbreviated New Drug Application (ANDA): 077120

Company: APOTEX INC

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
06/02/2008 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
02/04/2021 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/29/2010 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 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 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 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 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 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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