Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078956
Company: AUROBINDO PHARMA

Products on ANDA 078956

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078956

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
07/08/2022	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
07/08/2022	SUPPL-32	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/08/2022	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/06/2019	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
12/06/2019	SUPPL-26	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/06/2019	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
12/06/2019	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/19/2016	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/19/2016	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/19/2016	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
12/12/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/12/2014	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/12/2014	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/25/2012	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/25/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/30/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/28/2010	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/23/2010	SUPPL-2	Labeling-Container/Carton Labels, REMS-Proposal		Label is not available on this site.
09/22/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078956

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	078956	AUROBINDO PHARMA
LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET;ORAL	Prescription	No	AB	076708	DR REDDYS LABS LTD
LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET;ORAL	Prescription	No	AB	090169	GLENMARK PHARMS LTD
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	078625	RUBICON
LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET;ORAL	Prescription	No	AB	078525	TARO PHARM INDS
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	078956	AUROBINDO PHARMA
LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET;ORAL	Prescription	No	AB	076708	DR REDDYS LABS LTD
LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET;ORAL	Prescription	No	AB	090169	GLENMARK PHARMS LTD
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	078625	RUBICON
LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET;ORAL	Prescription	No	AB	078525	TARO PHARM INDS
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	078956	AUROBINDO PHARMA
LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET;ORAL	Prescription	No	AB	076708	DR REDDYS LABS LTD
LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET;ORAL	Prescription	No	AB	090169	GLENMARK PHARMS LTD
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	078625	RUBICON
LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET;ORAL	Prescription	No	AB	078525	TARO PHARM INDS
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	078956	AUROBINDO PHARMA
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET;ORAL	Prescription	No	AB	076708	DR REDDYS LABS LTD
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET;ORAL	Prescription	No	AB	090169	GLENMARK PHARMS LTD
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	078625	RUBICON
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET;ORAL	Prescription	No	AB	078525	TARO PHARM INDS
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