Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078690
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 10MG;100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;250MG TABLET, ORALLY DISINTEGRATING;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
07/31/2009 ORIG-1 Approval

Label is not available on this site.

CARBIDOPA AND LEVODOPA

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 078893 MYLAN
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 10MG;100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078690 SUN PHARM

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 078893 MYLAN
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078690 SUN PHARM

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 078893 MYLAN
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;250MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078690 SUN PHARM

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