Familial Hypercholesterolemia Heterozygous
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FDA approval · 2023-04-11FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental ANDA for Colesevelam Hydrochloride, allowing the marketing of a generic Colesevelam Hydrochloride produ…
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FDA approval · 2022-02-08FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Zhejiang Yongtai Pharmaceutical Co., Ltd.)
FDA approved a supplemental application for Rosuvastatin Calcium from Zhejiang Yongtai Pharmaceutical Co., Ltd., resulting in an approved su…
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FDA approval · 2019-05-21FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc., resulting in changes to …
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FDA approval · 2017-11-22FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Quallent Pharmaceuticals Health LLC)
FDA approved the original application for rosuvastatin calcium (generic rosuvastatin calcium) from Quallent Pharmaceuticals Health LLC. The …
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FDA approval · 2016-07-19FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Rising Pharma Holdings, Inc.)
FDA approved an original Abbreviated New Drug Application for rosuvastatin calcium from Rising Pharma Holdings, Inc.
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