Hyperphosphatemia
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FDA approval · 2020-03-25FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Sevelamer Carbonate from Aurobindo Pharma Limited, enabling its continued/expanded generic use.
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FDA approval · 2020-02-28FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)
The FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) submitted by Fresenius Medical Care Renal Therapies Grou…
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FDA approval · 2020-02-21FDA Approved: CALCIUM ACETATE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for calcium acetate capsules (667 mg) from Rising Pharma Holdings, Inc., a generic product.
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FDA approval · 2019-02-08FDA Approved: SEVELAMER HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Sevelamer hydrochloride as a generic product under an original ANDA from Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2018-11-08FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) submitted by Takeda, resulting in updated labeling for managing h…
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FDA approval · 2018-11-08FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Fosrenol (lanthanum carbonate) from Takeda Pharmaceuticals America, Inc. The update pertains…
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FDA approval · 2018-10-25FDA Approved: SEVELAMER CARBONATE FOR ORAL SUSPENSION — Original Application (Dr. Reddys Laboratories Inc)
FDA approved an original ANDA for Sevelamer carbonate for oral suspension from Dr. Reddy's Laboratories Inc.
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FDA approval · 2018-04-25FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)
The FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) submitted by Fresenius Medical Care Renal Therapies Grou…
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FDA approval · 2018-03-20FDA Approved: SEVELAMER CARBONATE — Original Application (Westminster Pharmaceuticals, LLC)
FDA approved Westminster Pharmaceuticals' sevelamer carbonate generic (ANDA200959) for controlling serum phosphorus in adults with chronic k…
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FDA approval · 2017-11-28FDA Approved: SEVELAMER CARBONATE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals’ generic Sevelamer carbonate (Original Application) for the treatment of hyperphosphatemia in adults wit…
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FDA approval · 2017-10-26FDA Approved: SEVELAMER CARBONATE — Original Application (Exelan Pharmaceuticals Inc.)
FDA approved a generic version of sevelamer carbonate (Sevelamer carbonate) from Exelan Pharmaceuticals Inc. for the treatment of hyperphosp…
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FDA approval · 2017-09-29FDA Approved: SEVELAMER CARBONATE — Original Application (DR. REDDY'S LABORATORIES LIMITED)
FDA approved the Sevelamer carbonate original application (ANDA206094) from Dr. Reddy's Laboratories Limited for the treatment of hyperphosp…
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FDA approval · 2017-08-11FDA Approved: LANTHANUM CARBONATE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' generic lantHanum carbonate under an original ANDA to treat hyperphosphatemia in adults with end-stage r…
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FDA approval · 2017-07-17FDA Approved: SEVELAMER CARBONATE — Original Application (Aurobindo Pharma Limited)
FDA approved the original ANDA for Sevelamer carbonate by Aurobindo Pharma Limited.
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FDA approval · 2017-06-13FDA Approved: SEVELAMER CARBONATE — Original Application (Aurobindo Pharma Limited)
FDA approves Sevelamer carbonate as a generic via an Original Application from Aurobindo Pharma Limited.
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FDA approval · 2016-11-25FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for Sevelamer carbonate (Renvela) from Sanofi-Aventis U.S. LLC, updating the product labeling. The c…
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FDA approval · 2016-11-25FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for sevelamer carbonate (Renvela) submitted by Sanofi-Aventis U.S. LLC.
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FDA approval · 2016-11-09FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Ferric Citrate submitted by Mylan Pharmaceuticals Inc., adding regulatory authorization for the …
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FDA approval · 2016-03-09FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for Sevelamer Hydrochloride submitted by Sanofi-Aventis U.S. LLC. This action constitutes a supp…
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FDA approval · 2016-03-09FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for Sevelamer carbonate from Sanofi-Aventis U.S. LLC.
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FDA approval · 2016-03-09FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for sevelamer carbonate, resulting in updated labeling for the product.
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FDA approval · 2016-02-24FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2016-02-24FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Fosrenol (lanthanum carbonate) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2015-10-26FDA Approved: CALCIUM ACETATE — Original Application (Westminster Pharmaceuticals, LLC)
The FDA approved the Original Application for calcium acetate from Westminster Pharmaceuticals, LLC, adding a generic calcium acetate produc…
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FDA approval · 2015-08-04FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Ferric Citrate filed by Mylan Pharmaceuticals, authorizing continued or expanded use of this…