Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079099
Company: GLENMARK PHARMS LTD

• Other Important Information from FDA

Products on ANDA 079099

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079099

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/079099Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2024	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
04/11/2024	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
02/10/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/10/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/10/2020	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/10/2020	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/10/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/10/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/10/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/10/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/08/2014	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/31/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/26/2012	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/28/2010	SUPPL-1	Labeling-Package Insert, REMS-Proposal, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 079099

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	079204	TARO
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	079204	TARO
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