Solid Organ Transplant Rejection Prophylaxis

• FDA approval · 2024-08-13
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  FDA approved a supplemental application for mycophenolate mofetil from Concord Biotech Limited under ANDA 212087.

• FDA approval · 2024-05-01
  FDA Approved: MYHIBBIN — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approved MYHIBBIN, a mycophenolate mofetil product from Azurity Pharmaceuticals, under an original application (NDA216482). This approva…

• FDA approval · 2017-04-11
  FDA Approved: SIROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sirolimus by Mylan Pharmaceuticals, authorizing changes to the approved product through a supple…

• FDA approval · 2013-09-27
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Mycophenolate mofetil from Strides Pharma Science Limited under the ANDA program. This action au…