Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-01-29FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' supplemental application for methylphenidate hydrochloride, a generic stimulant used to treat attention-de…
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FDA approval · 2024-12-18FDA Approved: LUMRYZ — Supplemental Application (Avadel CNS Pharmaceuticals, LLC)
FDA approved a supplemental application for Lumryz (sodium oxybate) from Avadel CNS Pharmaceuticals, LLC.
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FDA approval · 2024-12-17FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals, Inc.)
FDA approved a Teva supplemental application for a generic combination of four amphetamine salts (dextroamphetamine saccharate, amphetamine …
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FDA approval · 2024-12-17FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application from Granules Pharmaceuticals Inc. for methylphenidate hydrochloride granules, adding a new dosage f…
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FDA approval · 2024-11-18FDA Approved: XYWAV — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approved a supplemental application for XYWAV (calcium, magnesium, potassium, and sodium oxybates) submitted by Jazz Pharmaceuticals.
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FDA approval · 2024-10-25FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma, Inc.'s supplemental application for dextroamphetamine sulfate, confirming continued approval and updating label…
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FDA approval · 2024-10-16FDA Approved: LUMRYZ — Supplemental Application (Avadel CNS Pharmaceuticals, LLC)
The FDA approved a supplemental application for LUMRYZ (sodium oxybate) from Avadel CNS Pharmaceuticals, LLC.
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FDA approval · 2024-09-26FDA Approved: LUMRYZ — Supplemental Application (Avadel CNS Pharmaceuticals, LLC)
The FDA approved a supplemental application for LUMRYZ (sodium oxybate) submitted by Avadel CNS Pharmaceuticals, LLC.
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FDA approval · 2024-09-10FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)
FDA approved a supplemental application for a generic Dexmethylphenidate hydrochloride product from Nivagen Pharmaceuticals, expanding acces…
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FDA approval · 2024-08-30FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for a four-salt amphetamine combination (dextroamphetamine saccharate, amphetamine aspartate monohyd…
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FDA approval · 2024-08-30FDA Approved: METHYLPHENIDATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for methylphenidate submitted by Mylan Pharmaceuticals Inc. The approval covers the changes describe…
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FDA approval · 2024-08-30FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for Accord Healthcare's methylphenidate hydrochloride under an ANDA, adjusting the regulatory status…
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FDA approval · 2024-08-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride from Actavis Pharma, Inc., updating the product under an ANDA.
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FDA approval · 2024-06-14FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Sandoz Inc)
FDA approved a Supplemental Application from Sandoz Inc for a generic combination product containing dextroamphetamine saccharate, amphetami…
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FDA approval · 2024-06-03FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (KVK-TECH, INC.)
The FDA approved a supplemental application for methylphenidate hydrochloride from KVK-Tech, Inc., authorizing their generic product under a…
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FDA approval · 2024-05-30FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic formulation containing four amphetamine salt components (dextroamphetamine saccharate,…
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FDA approval · 2024-05-22FDA 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 changes to the product …
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FDA approval · 2024-05-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
FDA granted a supplemental approval for methylphenidate hydrochloride from Cranbury Pharmaceuticals, LLC, updating the approved generic prod…
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FDA approval · 2024-04-11FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for methylphenidate hydrochloride from Dr. Reddy's Laboratories Inc, updating the approval for the g…
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FDA approval · 2024-04-10FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Northstar Rx LLC)
The FDA approved a supplemental application for methylphenidate hydrochloride from Northstar Rx LLC, authorizing the generic product. Methyl…
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FDA approval · 2024-04-01FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for methylphenidate hydrochloride.
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FDA approval · 2024-04-01FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Elite Laboratories, Inc.)
The FDA approved Elite Laboratories, Inc.'s supplemental application for a fixed combination of amphetamine salts (dextroamphetamine sacchar…
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FDA approval · 2024-04-01FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE EXTENDED-RELEASE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's supplemental application for a generic mixed amphetamine salts extended-release product (dextroamphetamine…
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FDA approval · 2024-03-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for a generic product containing four amphetamine salt components, manufactured by Sun Pharmaceu…
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FDA approval · 2024-03-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' supplemental ANDA for a generic combination of amphetamine/dextroamphetamine salts used to treat attention…