Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077828
Company: SUN PHARM INDS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 50MG;200MG TABLET, EXTENDED RELEASE;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
08/23/2007 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
09/24/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/03/2013 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

CARBIDOPA AND LEVODOPA

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL Prescription No AB 202323 ACCORD HLTHCARE
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076212 APOTEX
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076521 IMPAX LABS
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075091 MYLAN
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077828 SUN PHARM INDS
SINEMET CR CARBIDOPA; LEVODOPA 25MG;100MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019856 MERCK SHARP DOHME

TABLET, EXTENDED RELEASE;ORAL; 50MG;200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 50MG;200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202323 ACCORD HLTHCARE
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 50MG;200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076212 APOTEX
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 50MG;200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076521 IMPAX LABS
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 50MG;200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075091 MYLAN
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 50MG;200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077828 SUN PHARM INDS
SINEMET CR CARBIDOPA; LEVODOPA 50MG;200MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019856 MERCK SHARP DOHME

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