Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077084
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Discontinued None No No
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Discontinued None 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/2005/077084ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/30/2011 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/30/2010 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/28/2009 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

04/23/2008 SUPPL-7 Labeling

Label is not available on this site.

04/23/2008 SUPPL-6 Labeling

Label is not available on this site.

07/09/2007 SUPPL-4 Labeling

Label is not available on this site.

03/31/2006 SUPPL-2 Labeling

Label is not available on this site.

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