Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202720
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Discontinued None No No
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;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
10/30/2014 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-9 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/21/2021 SUPPL-8 REMS - MODIFIED - D-N-A

Label is not available on this site.

01/15/2021 SUPPL-7 REMS - MODIFIED - D-N-A

Label is not available on this site.

11/21/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/13/2015 SUPPL-1 REMS-Proposal

Label is not available on this site.

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