Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090111
Company: VINTAGE PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;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
12/22/2009 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
08/11/2021 SUPPL-12 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/21/2021 SUPPL-11 REMS - MODIFIED - D-N-A

Label is not available on this site.

01/15/2021 SUPPL-10 REMS - MODIFIED - D-N-A

Label is not available on this site.

07/27/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

11/13/2015 SUPPL-8 REMS-Proposal

Label is not available on this site.

09/27/2013 SUPPL-7 REMS-Modified

Label is not available on this site.

08/01/2012 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/25/2012 SUPPL-4 REMS-Proposal

Label is not available on this site.

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