Heart Transplantation

• FDA approval · 2025-06-27
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approves a supplemental application for CellCept (mycophenolate mofetil hydrochloride) from Genentech, confirming an approved modificati…

• FDA approval · 2025-05-19
  FDA Approved: TACROLIMUS — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for tacrolimus filed by Accord Healthcare Inc. under ANDA 091195 for the generic product.

• FDA approval · 2024-08-13
  FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for MYFORTIC (mycophenolic acid) from Novartis. The approval expands its use for preventing orga…

• FDA approval · 2024-08-13
  FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Mycophenolic Acid submitted by Aurobindo Pharma Limited under an ANDA, approving changes to …

• FDA approval · 2024-08-13
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (ONESOURCE SPECIALTY PHARMA LIMITED)

  FDA approved a supplemental application for mycophenolate mofetil submitted by Onesource Specialty Pharma Limited. The action pertains to ch…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-08-13
  FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s supplemental application for mycophenolic acid, granting approval of the generic product under ANDA214630.…

• FDA approval · 2024-07-08
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  FDA approved a supplemental application for mycophenolate mofetil from Concord Biotech Limited, enabling approval of a generic formulation u…

• 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 · 2024-02-27
  FDA Approved: MYCOPHENOLIC ACID — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for generic mycophenolic acid from Aurobindo Pharma Limited. It is indicated as part of an immunosuppr…

• FDA approval · 2024-02-07
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for a generic version of mycophenolate mofetil from Hikma Pharmaceuticals USA, enabling continue…

• FDA approval · 2023-09-14
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for PROGRAF (tacrolimus) submitted by Astellas Pharma US, Inc.

• FDA approval · 2023-09-14
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for PROGRAF (tacrolimus) from Astellas, updating the labeling for its use as an immunosuppressant to…

• FDA approval · 2023-05-08
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for mycophenolate mofetil from Ascend Laboratories, LLC under ANDA203005.

• FDA approval · 2023-05-01
  FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)

  The FDA approved a supplemental application for tacrolimus by Sandoz Inc., resulting in a supplemental approval for the generic product. Thi…

• FDA approval · 2023-03-08
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Institutional LLC)

  FDA issued a supplemental approval for mycophenolate mofetil in a filing by Mylan Institutional LLC.

• FDA approval · 2022-12-21
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Lannett's generic mycophenolate mofetil, authorizing its market approval as a generic immunosupp…

• FDA approval · 2021-10-22
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Cellcept (mycophenolate mofetil hydrochloride) submitted by Genentech, Inc.

• FDA approval · 2021-08-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Mycophenolate mofetil from Ascend Laboratories, LLC under ANDA 203005, indicating approval of a …

• FDA approval · 2021-08-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  FDA approved a supplemental application for a generic version of mycophenolate mofetil from Concord Biotech Limited.

• FDA approval · 2021-05-17
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's supplemental application for mycophenolate mofetil (ANDA 090253), allowing continued marketing of the gener…

• FDA approval · 2021-04-21
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for mycophenolate mofetil from Accord Healthcare Inc., authorizing the generic product's continued m…

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

  FDA approves a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., reflecting a labeling update for this…

• FDA approval · 2021-01-15
  FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare Inc.'s mycophenolic acid, supporting its continued regulatory status as a gene…

• FDA approval · 2020-08-04
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for mycophenolate mofetil, a generic immunosuppressant used to prevent organ transplant rejecti…

• FDA approval · 2020-08-04
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Mycophenolate mofetil filed by Strides Pharma Science Limited.