Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203424
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 12.5MG;200MG;50MG TABLET;ORAL Discontinued None No No
CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 18.75MG;200MG;75MG TABLET;ORAL Discontinued None No No
CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 25MG;200MG;100MG TABLET;ORAL Discontinued None No No
CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 31.25MG;200MG;125MG TABLET;ORAL Discontinued None No No
CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 37.5MG;200MG;150MG TABLET;ORAL Discontinued None No No
CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 50MG;200MG;200MG TABLET;ORAL Discontinued None 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
08/13/2020 ORIG-1 Approval

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