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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076701
Company: DR REDDYS LABS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, FOR SUSPENSION;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, FOR SUSPENSION;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
01/22/2009 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/076701Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
03/15/2012 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/29/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
03/15/2012 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
01/12/2011 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
02/23/2010 SUPPL-3 Labeling-Medication Guide, REMS-Modified

Label is not available on this site.
09/21/2009 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.
09/21/2009 SUPPL-1 Labeling

Label is not available on this site.

LAMOTRIGINE

TABLET, FOR SUSPENSION;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, FOR SUSPENSION;ORAL Prescription Yes AB 020764 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 201168 ALEMBIC
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 090401 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 076701 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 079099 GLENMARK PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 076928 WATSON LABS
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 078009 ZYDUS PHARMS USA INC

TABLET, FOR SUSPENSION;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, FOR SUSPENSION;ORAL Prescription Yes AB 020764 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 201168 ALEMBIC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 090401 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 076701 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 079099 GLENMARK PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 076928 WATSON LABS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 078009 ZYDUS PHARMS USA INC
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