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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077090
Company: APOTEX

Other Important Information from FDA

Products on ANDA 077090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	AB	No	No
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077090ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2024	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/30/2017	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/29/2016	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
02/29/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/28/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/29/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/09/2008	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077090

LEFLUNOMIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARAVA	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	Yes	AB	020905	SANOFI AVENTIS US
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	212453	ABHAI LLC
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	213497	AET PHARMA
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	091369	ALEMBIC PHARMS LTD
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	077090	APOTEX
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	213652	AUROBINDO PHARMA
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	077087	FOSUN WANBANG
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	077086	HERITAGE
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	211863	LUPIN
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	212308	ZYDUS LIFESCIENCES

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARAVA	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	Yes	AB	020905	SANOFI AVENTIS US
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	212453	ABHAI LLC
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	213497	AET PHARMA
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	091369	ALEMBIC PHARMS LTD
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	077090	APOTEX
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	213652	AUROBINDO PHARMA
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	077087	FOSUN WANBANG
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	077086	HERITAGE
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	211863	LUPIN
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	212308	ZYDUS LIFESCIENCES

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