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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091369
Company: ALEMBIC PHARMS LTD

Products on ANDA 091369

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 091369

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2011	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 091369

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 INC
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	213652	AUROBINDO PHARMA
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	077086	HERITAGE PHARMS
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	211863	LUPIN LTD
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	077087	WANBANG BIOPHARMS
LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET;ORAL	Prescription	No	AB	212308	ZYDUS

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 INC
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	213652	AUROBINDO PHARMA
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	077086	HERITAGE PHARMS
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	211863	LUPIN LTD
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	077087	WANBANG BIOPHARMS
LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET;ORAL	Prescription	No	AB	212308	ZYDUS

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