Narcolepsy with Cataplexy
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FDA approval · 2025-11-05FDA Approved: SODIUM OXYBATE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic sodium oxybate under an original Abbreviated New Drug Application, enabling a generic option fo…
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FDA approval · 2025-09-10FDA Approved: SODIUM OXYBATE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved the original ANDA for sodium oxybate by Amneal Pharmaceuticals LLC, establishing a generic version of the drug. The approved in…
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FDA approval · 2017-04-19FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc., marking an additional regulatory act…
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FDA approval · 2012-12-17FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc., resulting in updated labeling.
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FDA approval · 2006-11-13FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate from Hikma Pharmaceuticals USA Inc.
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