MARKET APPROVALS
Market Approvals
Amarex has helped obtain the following market approvals:
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2020, 510(k) Approval, 1copy COVID-19 qPCR Multi Kit, Infectious Disease
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2020, De Novo Approval, Endeavor RX, ADHD
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2019, De Novo Approval, Weight Management Aid, Gastroenterology
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2019, 510(k) Approval, Vstrip H. pylori Antigen Rapid Test, Infectious Disease Diagnostic
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2018, NDA Approval, Diacomit, Anticonvulsant
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2017, 510(k) Approval, Gastroenterology/Urology
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2016, PMA Approval, Dermal Regeneration Matrix, Wound Healing Device
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2015, 510(k) Approval, BondEase Topical Skin Adhesive, Wound Healing Device
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2010/2015, PMA Approval, INSTI HIV-1/HIV-2 Antibody Test Kit, Diagnostic
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2013, NDA Approval, Brisdelle, Vasomotor Symptoms
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2013, NDA Approval, Pediatric Inflammatory Disease
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2012, NDA Approval, Pexeva, Depression & Anxiety
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2012, NDA Approval, Pain Management
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2012, PMA Approval, therascreen KRAS RGQ PCR Kit, Oncology Diagnostic
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2011, PMA Approval, Solesta, Gastroenterology
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2009, NDA Approval, QuitPak, Addiction
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2008, NDA Approval, Amoxicillin PULSYS, Infectious Disease
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2008, NDA Approval, Xenazine, Central Nervous System
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2002, NDA Approval, Abilify, Schizophrenia
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2001, NDA Approval, Adderall XR, ADHD
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2001, PMA Approval, OrCel, Wound Healing Device
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2001, PMA Approval, Remnant-Like Particles-Cholesterol (RLP-C) Assay, Diagnostic
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1999, NDA Approval, Pletal, Cardiovascular
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1998, NDA Approval, RAXAR, Infectious Disease