Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077783
Company: CIPLA
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
11/01/2010 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
10/23/2018 SUPPL-14 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

10/23/2018 SUPPL-13 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/20/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

09/20/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/20/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/20/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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