Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077086
Company: HERITAGE PHARMS INC
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/2005/077086ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/18/2017 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

02/15/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/29/2011 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

08/30/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

10/29/2008 SUPPL-6 Labeling

Label is not available on this site.

03/02/2006 SUPPL-2 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 091369 ALEMBIC PHARMS LTD
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077090 APOTEX INC
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077083 BARR
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077086 HERITAGE PHARMS INC
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077084 TEVA PHARMS

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 091369 ALEMBIC PHARMS LTD
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077090 APOTEX INC
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077083 BARR
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077086 HERITAGE PHARMS INC
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077084 TEVA PHARMS

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