Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203733
Company: ACTAVIS ELIZABETH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 250MG 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
11/13/2013 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
06/14/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LAMOTRIGINE

TABLET, EXTENDED RELEASE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203733 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM

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