Pancreas Transplant Rejection

• FDA approval · 2024-08-13
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)

  FDA approves Accord Healthcare's supplemental application for generic Mycophenolate mofetil. The approval supports continued use for prevent…

• FDA approval · 2021-08-11
  FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for mycophenolic acid submitted by Apotex Corp.

• 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 · 2019-09-17
  FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)

  The FDA approved a supplemental application for tacrolimus from Sandoz Inc., resulting in changes to the approved product, such as labeling …

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• FDA approval · 2019-06-11
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for Prograf (tacrolimus) filed by Astellas Pharma US, Inc. The action updates the labeling to re…

• FDA approval · 2018-05-24
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

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

• FDA approval · 2016-06-22
  FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)

  The FDA approved a supplemental application for ENVARSUS XR (tacrolimus) submitted by Veloxis Pharmaceuticals, Inc., adding/updating its ind…