Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090606
Company: OXFORD PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG 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
07/16/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/13/2015 SUPPL-7 REMS-Modified

Label is not available on this site.

09/27/2013 SUPPL-6 REMS-Modified

Label is not available on this site.

08/01/2012 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/25/2012 SUPPL-3 REMS-Proposal

Label is not available on this site.

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