Organ Transplant Rejection

• FDA approval · 2015-11-13
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application from Ascend Laboratories, LLC for Mycophenolate mofetil (ANDA 200197).

• FDA approval · 2015-11-13
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for mycophenolate mofetil by Hikma Pharmaceuticals USA Inc. under the existing ANDA, enabling co…

• FDA approval · 2012-09-25
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., potentially expanding the drug’s indi…

• FDA approval · 2012-06-28
  FDA Approved: TACROLIMUS — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s supplemental application for tacrolimus (generic) to update the product, which is used to prevent orga…

• FDA approval · 2011-11-04
  FDA Approved: TACROLIMUS — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for tacrolimus submitted by Padagis Israel Pharmaceuticals Ltd.

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• FDA approval · 2010-05-12
  FDA Approved: TACROLIMUS — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved Tacrolimus from Quallent Pharmaceuticals Health LLC under Original Application (ANDA 090509). The generic tacrolimus is approve…

• FDA approval · 2010-02-04
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for mycophenolate mofetil from Mylan Pharmaceuticals, updating the labeling under the ANDA to suppor…

• FDA approval · 2010-02-04
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for mycophenolate mofetil from Mylan Pharmaceuticals, approving its generic product for prevention o…

• FDA approval · 2009-05-19
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for PROGRAF (tacrolimus) submitted by Astellas Pharma US, Inc., related to its labeling/indicati…

• FDA approval · 2009-05-04
  FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for Mycophenolate mofetil as a generic product from Mylan Pharmaceuticals Inc. to prevent organ transp…

• FDA approval · 2008-01-14
  FDA Approved: SIROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for sirolimus submitted by Mylan Pharmaceuticals Inc. (supplemental NDA approval).

• FDA approval · 2006-05-08
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for cyclosporine (Apotex Corp.) under an ANDA, indicating approval of a supplemental update to this …