Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090607
Company: ALEMBIC PHARMS 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
01/13/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090607Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/02/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/02/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/02/2016 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/02/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/12/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/12/2014 SUPPL-6 Labeling-Medication Guide

Label is not available on this site.

12/12/2014 SUPPL-5 Labeling-Medication Guide, Labeling-Patient Package Insert

Label is not available on this site.

12/12/2014 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/18/2012 SUPPL-3 Labeling-Medication Guide, REMS

Label is not available on this site.

03/15/2012 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/15/2012 SUPPL-1 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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