Heart Transplant Rejection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-04-21FDA 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…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for Mycophenolate mofetil from Strides Pharma Science Limited (ANDA 090055).
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Slate Run Pharmaceuticals, LLC)
FDA approved a supplemental application for mycophenolic acid from Slate Run Pharmaceuticals, LLC.
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for Mycophenolate mofetil (ANDA 203859) from Mylan Institutional LLC.
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FDA approval · 2021-02-10FDA 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 …
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FDA approval · 2021-01-15FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Cellcept (mycophenolate mofetil) from Genentech, Inc. The supplementation concerns labeling …
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FDA approval · 2021-01-15FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CellCept (mycophenolate mofetil) from Genentech.
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FDA approval · 2021-01-15FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil hydrochloride) filed by Genentech, Inc., indicating an expansion…
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FDA label_change · 2021-01-15FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA issued a supplemental approval for mycophenolate mofetil (Hikma) to update the drug's labeling under an existing approval.
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FDA approval · 2021-01-15FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)
FDA approved a supplemental application for a generic version of mycophenolate mofetil from Concord Biotech Limited.
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FDA approval · 2021-01-15FDA 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…
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FDA approval · 2021-01-15FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Cellcept (mycophenolate mofetil) filed by Genentech, expanding its labeling for organ transplant…
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FDA approval · 2021-01-15FDA 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…
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FDA label_change · 2021-01-15FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for mycophenolate mofetil from Ascend Laboratories, LLC, to update labeling for the generic product.
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FDA approval · 2021-01-15FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved Meitheal Pharmaceuticals' original application for generic mycophenolate mofetil, expanding access to this immunosuppressiv…
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FDA approval · 2020-12-03FDA Approved: TACROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for tacrolimus submitted by Mylan Pharmaceuticals Inc.
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FDA approval · 2020-11-12FDA Approved: TACROLIMUS — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' tacrolimus as a new generic to prevent organ transplant rejection.
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FDA approval · 2020-11-10FDA 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…
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FDA approval · 2020-11-10FDA 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…
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FDA approval · 2020-11-10FDA 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…
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FDA label_change · 2020-11-03FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for MYFORTIC (mycophenolic acid) from Novartis, resulting in updates to the product labeling.
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FDA approval · 2020-08-12FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' supplemental application for mycophenolate mofetil, granting approval of a generic product for preventing …
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FDA approval · 2020-08-12FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for mycophenolate mofetil submitted by Ascend Laboratories, LLC. This action updates the product's r…
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FDA approval · 2020-07-31FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (CONCORD BIOTECH LIMITED)
FDA approved the Original Application for mycophenolate mofetil from Concord Biotech Limited, providing a generic version of the immunosuppr…
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FDA approval · 2020-06-16FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc. for the generic formulation.