Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077087
Company: FOSUN PHARMA
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
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/2005/077087ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/03/2020 SUPPL-14 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/06/2017 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

11/09/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

11/09/2015 SUPPL-11 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

04/27/2011 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

08/17/2009 SUPPL-7 Labeling

Label is not available on this site.

04/23/2008 SUPPL-2 Labeling

Label is not available on this site.

12/04/2007 SUPPL-1 Labeling

Label is not available on this site.

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 091369 ALEMBIC PHARMS LTD
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077090 APOTEX INC
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077087 FOSUN PHARMA
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077086 HERITAGE PHARMS INC
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 211863 LUPIN LTD
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 091369 ALEMBIC PHARMS LTD
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077090 APOTEX INC
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077087 FOSUN PHARMA
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077086 HERITAGE PHARMS INC
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 211863 LUPIN LTD
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 212308 ZYDUS

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