Heart Transplant Rejection

• FDA label_change · 2024-08-13
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Mycophenolate mofetil from Endo USA, Inc., updating the drug's labeling.

• FDA label_change · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA issued a supplemental approval for mycophenolate mofetil (Hikma) to update the drug's labeling under an existing approval.

• FDA label_change · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for mycophenolate mofetil from Ascend Laboratories, LLC, to update labeling for the generic product.

• FDA label_change · 2020-11-03
  FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for MYFORTIC (mycophenolic acid) from Novartis, resulting in updates to the product labeling.

• FDA label_change · 2019-12-13
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CellCept (mycophenolate mofetil hydrochloride) submitted by Genentech, Inc., influencing labelin…

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• FDA label_change · 2015-11-06
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)

  FDA supplemental approval for mycophenolate mofetil by Accord Healthcare Inc., resulting in labeling changes for the product.

• FDA label_change · 2013-09-27
  FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Myfortic (mycophenolic acid) from Novartis. The approval updates the labeling to reflect changes…