Liver Transplant Rejection

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

  The FDA approved a supplemental application for mycophenolate mofetil from Sandoz Inc.

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

  FDA approves Accord Healthcare's supplemental application for mycophenolate mofetil. The generic product is approved for use in preventing o…

• FDA approval · 2021-05-04
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for mycophenolate mofetil submitted by Mylan Pharmaceuticals, updating labeling and/or indicatio…

• FDA approval · 2021-04-21
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

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

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

  The FDA approved a supplemental application for mycophenolate mofetil from Mylan Pharmaceuticals, indicating an approved change to the exist…

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• FDA approval · 2021-04-21
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)

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

• FDA approval · 2021-04-21
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  FDA approved a supplemental application for mycophenolate mofetil by Concord Biotech Limited, enabling continued marketing of the immunosupp…

• FDA approval · 2021-04-21
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (VistaPharm, LLC)

  The FDA approved a supplemental application for mycophenolate mofetil from VistaPharm, LLC, enabling continued marketing of a generic versio…

• FDA approval · 2021-04-21
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Mycophenolate mofetil from Strides Pharma Science Limited (ANDA 090055).

• FDA approval · 2021-04-21
  FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Slate Run Pharmaceuticals, LLC)

  FDA approved a supplemental application for mycophenolic acid from Slate Run Pharmaceuticals, LLC.

• FDA approval · 2021-04-21
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for Mycophenolate mofetil (ANDA 203859) from Mylan Institutional LLC.

• FDA approval · 2021-02-10
  FDA Approved: MYCOPHENOLIC ACID — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved a generic mycophenolic acid product (ANDA 214376) from Slate Run Pharmaceuticals for prophylaxis of organ transplant rejection …

• FDA approval · 2021-01-15
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Cellcept (mycophenolate mofetil) from Genentech, Inc. The supplementation concerns labeling …

• FDA approval · 2021-01-15
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CellCept (mycophenolate mofetil) from Genentech.

• FDA approval · 2021-01-15
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil hydrochloride) filed by Genentech, Inc., indicating an expansion…

• FDA approval · 2021-01-15
  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 · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  The FDA approved Concord Biotech Limited's supplemental application for mycophenolate mofetil, adding a new generic product (ANDA 212087) to…

• FDA approval · 2021-01-15
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Cellcept (mycophenolate mofetil) filed by Genentech, expanding its labeling for organ transplant…

• FDA approval · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  FDA approved the supplemental application for mycophenolate mofetil submitted by Strides Pharma Science Limited. The approval updates the dr…

• FDA approval · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' original application for generic mycophenolate mofetil, expanding access to this immunosuppressiv…

• FDA approval · 2020-12-03
  FDA Approved: TACROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for tacrolimus submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2020-11-12
  FDA Approved: TACROLIMUS — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' tacrolimus as a new generic to prevent organ transplant rejection.

• FDA approval · 2020-11-10
  FDA Approved: TACROLIMUS — Original Application (NORTHSTAR RX LLC)

  FDA approved tacrolimus as a generic via an original ANDA from NORTHSTAR RX LLC. The approval covers tacrolimus for prevention of organ tran…

• FDA approval · 2020-11-10
  FDA Approved: TACROLIMUS — Original Application (Stellon Biotech Inc.)

  FDA approved the original application for tacrolimus by Stellon Biotech Inc., making a generic oral tacrolimus available. The approval cover…

• FDA approval · 2020-11-10
  FDA Approved: TACROLIMUS — Original Application (Biocon Pharma Inc.)

  FDA approved a Tacrolimus generic from Biocon Pharma Inc. (ANDA212297) for immunosuppression to prevent organ transplant rejection in kidney…