Organ Transplant Rejection Prophylaxis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-08-13FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Mycophenolic Acid submitted by Aurobindo Pharma Limited under an ANDA, approving changes to …
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FDA approval · 2024-08-09FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Accord Healthcare Inc.'s mycophenolate mofetil under an ANDA. The approval updates the generic p…
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FDA approval · 2024-05-29FDA Approved: MYCOPHENOLIC ACID — Original Application (Novugen Pharma (USA) LLC.)
FDA approved an original application for mycophenolic acid, enabling a generic version of the immunosuppressant used to prevent organ transp…
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FDA approval · 2023-05-01FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
The FDA approved a supplemental application for tacrolimus by Sandoz Inc., resulting in a supplemental approval for the generic product. Thi…
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FDA approval · 2022-08-02FDA Approved: CYCLOSPORINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved the original application for cyclosporine (generic) from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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FDA approval · 2022-02-02FDA Approved: CYCLOSPORINE — Original Application (Mylan Pharmaceuticals Inc.)
The FDA approved Mylan Pharmaceuticals' original application for cyclosporine, a generic immunosuppressant product. This makes a generic cyc…
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., indicating an approved change to the …
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FDA approval · 2021-08-11FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Mycophenolic acid from Accord Healthcare Inc., updating regulatory status for this generic produ…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., updating or expanding its labeled ind…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Accord Healthcare Inc., authorizing the generic product's continued m…
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FDA approval · 2021-01-07FDA Approved: AZATHIOPRINE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for azathioprine sodium from Hikma Pharmaceuticals USA Inc., updating the generic product's approval…
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FDA approval · 2019-12-13FDA Approved: MYCOPHENOLIC ACID — Original Application (CONCORD BIOTECH LIMITED)
FDA approves Concord Biotech Limited's original application for mycophenolic acid, enabling its generic availability. This immunosuppressant…
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FDA approval · 2019-11-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)
The FDA approved a supplemental application for mycophenolate mofetil from Concord Biotech Limited.
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FDA approval · 2019-04-23FDA Approved: AZATHIOPRINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for azathioprine from Zydus Lifesciences Limited.
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FDA approval · 2015-11-13FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental abbreviated new drug application for Mycophenolate mofetil from Strides Pharma Science Limited.
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FDA approval · 2015-11-06FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's supplemental application for mycophenolate mofetil (generic) under an existing ANDA.
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FDA approval · 2015-06-01FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Mycophenolate mofetil from Accord Healthcare Inc., updating the approved generic product.
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FDA approval · 2015-04-29FDA Approved: TACROLIMUS — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)
The FDA approved a supplemental application for tacrolimus from E. Fougera & Co., a division of Fougera Pharmaceuticals, LLC. The action per…
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FDA approval · 2012-09-25FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil hydrochloride) submitted by Genentech, Inc.
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FDA approval · 2012-06-27FDA Approved: TACROLIMUS — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for tacrolimus submitted by Quallent Pharmaceuticals Health LLC.
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FDA approval · 2011-08-31FDA Approved: TACROLIMUS — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s original ANDA for tacrolimus, enabling a generic version of the drug. The approval covers use for prev…
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FDA approval · 2009-09-24FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for NEORAL (cyclosporine) from Novartis Pharmaceuticals Corporation, authorizing changes to the …
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FDA approval · 2009-05-04FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's original application for mycophenolate mofetil, an immunosuppressant used to prevent organ transplant rejec…
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FDA approval · 2009-03-24FDA 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…
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FDA approval · 2008-07-29FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved the original application for MYCOPHENOLATE MOFETIL as a generic product from Hikma Pharmaceuticals USA Inc.