Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078691
Company: LUPIN LTD
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
06/01/2010 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
08/22/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

04/12/2013 SUPPL-3 REMS-Modified, Labeling

Label is not available on this site.

06/17/2011 SUPPL-2 Labeling-Package Insert

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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