Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079099
Company: GLENMARK PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;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
02/19/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/079099Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/2014 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/31/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/26/2012 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/28/2010 SUPPL-1 Labeling-Package Insert, REMS-Proposal, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

LAMOTRIGINE

TABLET, CHEWABLE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL CD LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription Yes AB 020764 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 201168 ALEMBIC PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 090401 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 076701 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 079099 GLENMARK PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 200220 JUBILANT GENERICS
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 079204 TARO
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 076420 TEVA
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 076928 WATSON LABS
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 078009 ZYDUS PHARMS USA INC

TABLET, CHEWABLE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL CD LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription Yes AB 020764 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 201168 ALEMBIC PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 090401 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 076701 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 079099 GLENMARK PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 200220 JUBILANT GENERICS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 079204 TARO
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 076420 TEVA
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 076928 WATSON LABS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 078009 ZYDUS PHARMS USA INC

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