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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201168
Company: ALEMBIC

Products on ANDA 201168

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 201168

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2014	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/17/2019	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/17/2019	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/29/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/29/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/29/2017	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 201168

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

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