Heart Transplant Rejection Prophylaxis

• FDA approval · 2025-02-20
  FDA Approved: TACROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for tacrolimus from Mylan Pharmaceuticals Inc., authorizing the generic to be marketed for the preve…

• FDA approval · 2024-02-07
  FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)

  FDA approves a supplemental application for tacrolimus from Sandoz Inc., resulting in a generic tacrolimus product becoming available.

• FDA approval · 2023-09-26
  FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for NEORAL (cyclosporine) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-04-17
  FDA Approved: TACROLIMUS — Original Application (Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd)

  FDA approved the original application for tacrolimus (generic) from Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

• FDA approval · 2021-11-02
  FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's original application for mycophenolate mofetil (generic) to prevent organ transplant rejection.…

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

  FDA approves a supplemental application for mycophenolate mofetil from Meitheal Pharmaceuticals, reflecting an updated approval pathway for …

• FDA approval · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Mycophenolate mofetil (Sandoz Inc), signaling an updated/expanded use or labeling for the produc…

• FDA approval · 2019-09-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)

  FDA supplemental approval for mycophenolate mofetil (Sandoz) under an ANDA; the action updates labeling related to prevention of organ trans…

• FDA approval · 2019-01-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for mycophenolate mofetil submitted by Ascend Laboratories, LLC. The action relates to the ANDA 2030…

• 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 · 2015-11-13
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for mycophenolate mofetil from Sandoz Inc, updating the drug’s existing approval under a supplem…

• FDA approval · 2015-11-09
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for mycophenolate mofetil from Sandoz Inc, confirming the generic product's approval under an AN…

• FDA approval · 2014-01-16
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for cyclosporine from Apotex Corp, authorizing changes under the generic product's regulatory fi…

• FDA approval · 2012-10-12
  FDA Approved: TACROLIMUS — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for tacrolimus from Quallent Pharmaceuticals Health LLC under an ANDA, effectively approving a gener…

• FDA approval · 2011-07-14
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for PROGRAF (tacrolimus) filed by Astellas Pharma US, Inc. This action approves an addition/modifica…

• FDA approval · 2009-09-09
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for mycophenolate mofetil submitted by Hikma Pharmaceuticals USA Inc., updating the labeling for…

• FDA approval · 2009-03-24
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Sandoz to market a generic mycophenolate mofetil, an immunosuppressant used to prevent organ…

• FDA approval · 2008-10-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's original application for a generic version of mycophenolate mofetil. The product is indicated for prophylaxis of o…

• FDA approval · 2008-07-29
  FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic mycophenolate mofetil under an Original Application, making a generic immunosuppressan…

• FDA approval · 2007-12-20
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

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