Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078669
Company: ACTAVIS TOTOWA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Discontinued None No No
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Discontinued None No No
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Discontinued None No No
LAMOTRIGINE LAMOTRIGINE 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
04/08/2011 ORIG-1 Approval Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078669Orig1s000Approv.pdf

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