Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076212
Company: APOTEX

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
06/16/2004 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
11/17/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
12/30/2010 SUPPL-9 Labeling

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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