Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077757
Company: CARACO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET; ORAL None (Tentative Approval) None No No
LAMOTRIGINE LAMOTRIGINE 100MG TABLET; ORAL None (Tentative Approval) None No No
LAMOTRIGINE LAMOTRIGINE 150MG TABLET; ORAL None (Tentative Approval) None No No
LAMOTRIGINE LAMOTRIGINE 200MG TABLET; ORAL None (Tentative Approval) 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
11/09/2007 ORIG-1 Tentative Approval

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