Solid Organ Transplantation

• FDA approval · 2021-08-11
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil hydrochloride) submitted by Genentech, authorizing an update to …

• FDA approval · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  FDA approved the supplemental application for mycophenolate mofetil submitted by Strides Pharma Science Limited. The approval updates the dr…

• FDA approval · 2020-06-16
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc. for the generic formulation.

• FDA approval · 2018-05-24
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Prograf (tacrolimus) from Astellas Pharma US, Inc. to update its labeling and indications.

• FDA approval · 2015-11-13
  FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Archis Pharma LLC)

  FDA approved Archis Pharma LLC's supplemental application for Mycophenolic acid, enabling the continued marketing of this product under an a…

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• FDA approval · 2015-05-28
  FDA Approved: SIROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for sirolimus submitted by Mylan Pharmaceuticals, granting regulatory approval for changes to th…

• FDA approval · 2012-08-31
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for mycophenolate mofetil from Strides Pharma Science Limited. This approval supports continued …