Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078947
Company: TORRENT PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;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
01/27/2009 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
06/16/2017 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

06/16/2017 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-21 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

03/14/2012 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

01/31/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

09/29/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

07/28/2010 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/21/2010 SUPPL-8 REMS-Modified

Label is not available on this site.

09/21/2009 SUPPL-6 REMS-Proposal, Labeling

Label is not available on this site.

09/21/2009 SUPPL-5 Labeling

Label is not available on this site.

LAMOTRIGINE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL LAMOTRIGINE 25MG TABLET;ORAL Prescription Yes AB 020241 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 090607 ALEMBIC PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 200694 ALKEM LABS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 078625 APOTEX INC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 078956 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 077783 CIPLA LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 076708 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 090169 GLENMARK GENERICS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 079132 JUBILANT CADISTA
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 078691 LUPIN LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 077420 MYLAN
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 078525 TARO PHARM INDS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 076388 TEVA
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 078947 TORRENT PHARMS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 090170 UNICHEM LABS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Prescription No AB 077633 ZYDUS PHARMS USA

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL LAMOTRIGINE 100MG TABLET;ORAL Prescription Yes AB 020241 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 090607 ALEMBIC PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 200694 ALKEM LABS LTD
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 078625 APOTEX INC
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 078956 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 077783 CIPLA LTD
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 076708 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 090169 GLENMARK GENERICS
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 079132 JUBILANT CADISTA
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 078691 LUPIN LTD
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 077420 MYLAN
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 078525 TARO PHARM INDS
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 076388 TEVA
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 078947 TORRENT PHARMS
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 090170 UNICHEM LABS LTD
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Prescription No AB 077633 ZYDUS PHARMS USA

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL LAMOTRIGINE 150MG TABLET;ORAL Prescription Yes AB 020241 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 090607 ALEMBIC PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 200694 ALKEM LABS LTD
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 078625 APOTEX INC
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 078956 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 077783 CIPLA LTD
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 076708 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 090169 GLENMARK GENERICS
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 079132 JUBILANT CADISTA
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 078691 LUPIN LTD
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 077420 MYLAN
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 078525 TARO PHARM INDS
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 076388 TEVA
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 078947 TORRENT PHARMS
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 090170 UNICHEM LABS LTD
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Prescription No AB 077633 ZYDUS PHARMS USA

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL LAMOTRIGINE 200MG TABLET;ORAL Prescription Yes AB 020241 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 090607 ALEMBIC PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 200694 ALKEM LABS LTD
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 078625 APOTEX INC
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 078956 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 077783 CIPLA LTD
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 076708 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 090169 GLENMARK GENERICS
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 079132 JUBILANT CADISTA
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 078691 LUPIN LTD
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 077420 MYLAN
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 078525 TARO PHARM INDS
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 076388 TEVA
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 078947 TORRENT PHARMS
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 090170 UNICHEM LABS LTD
LAMOTRIGINE LAMOTRIGINE 200MG TABLET;ORAL Prescription No AB 077633 ZYDUS PHARMS USA

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