Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-12-11FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Elite Laboratories, Inc.)
The FDA approved Elite Laboratories' generic mixed amphetamine salts product under an original ANDA. The product contains four salt forms of…
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FDA approval · 2019-11-19FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) from Novartis Pharmaceuticals Corporation.
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FDA approval · 2019-10-07FDA Approved: SUNOSI — Supplemental Application (Axsome Therapeutics, Inc.)
FDA approved a supplemental application for Sunosi (solriamfetol) from Axsome Therapeutics, Inc.
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FDA approval · 2019-09-03FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (XLCare Pharmaceuticals, Inc.)
FDA approved methylphenidate hydrochloride from XLCare Pharmaceuticals, Inc. via an Original Application (ANDA) for generic methylphenidate …
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FDA approval · 2019-08-14FDA Approved: WAKIX — Original Application (Harmony Biosciences, LLC)
FDA approved Wakix (pitolisant hydrochloride) in an original application for the treatment of excessive daytime sleepiness in adults with na…
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FDA approval · 2019-08-05FDA Approved: AMPHETAMINE SULFATE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals Inc.'s amphetamine sulfate as an Original Application under the ANDA212619, marking a generic product …
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FDA approval · 2019-07-03FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for a fixed-dose combination of four amphetamine salts (dextroamphetamine saccharate, amphetamine as…
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FDA approval · 2019-05-23FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals Inc.'s methylphenidate hydrochloride granules as an original generic drug application.
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FDA approval · 2019-05-09FDA Approved: ARMODAFINIL — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved Mylan's original ANDA for armodafinil, a generic wakefulness-promoting drug, for the treatment of excessive daytime sleepiness …
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FDA approval · 2019-04-22FDA Approved: MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR — Original Application (SpecGx LLC)
FDA approved the original ANDA for MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR, a generic extended-release amphetamine formulation…
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FDA approval · 2019-04-17FDA Approved: AMPHETAMINE SULFATE — Original Application (Aurolife Pharma, LLC)
FDA approved the original application for Amphetamine Sulfate from Aurolife Pharma, LLC, expanding generic options for this stimulant medica…
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FDA approval · 2019-03-20FDA Approved: SUNOSI — Original Application (Axsome Therapeutics, Inc.)
Sunosi (solriamfetol) received FDA approval via an Original Application for the treatment of excessive daytime sleepiness in adults with nar…
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FDA approval · 2019-02-01FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Neolpharma, Inc.)
FDA approved Neolpharma, Inc.'s methylphenidate hydrochloride generic under an original ANDA. The product is indicated for attention-deficit…
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FDA approval · 2019-01-22FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approves ANI Pharmaceuticals' generic combination of amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate monohydrate,…
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FDA approval · 2019-01-15FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) from Amneal Pharmaceuticals LLC.
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FDA approval · 2018-12-07FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Elite Laboratories, Inc.)
FDA approved Elite Laboratories, Inc.'s original ANDA for a combination amphetamine product consisting of dextroamphetamine saccharate, amph…
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FDA approval · 2018-11-21FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals Inc.'s methylphenidate hydrochloride generic under an original ANDA.
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FDA approval · 2018-09-26FDA Approved: AMPHETAMINE SULFATE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's generic amphetamine sulfate under an Original Application, enabling a generic version of this s…
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FDA approval · 2018-07-16FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
The FDA has approved a supplemental application from Prasco Laboratories for a mixed salt formulation of dextroamphetamine and amphetamine (…
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FDA approval · 2018-03-22FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma, Inc.'s original ANDA for methylphenidate hydrochloride, establishing a generic version of the stimulant used to…
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FDA approval · 2018-03-21FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)
FDA approved the generic methylphenidate hydrochloride from Actavis Pharma under an original ANDA (ANDA076655).
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FDA approval · 2018-03-06FDA Approved: ARMODAFINIL — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's armodafinil as a generic product under an Original ANDA. It is indicated for excessive daytime sleep…
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FDA approval · 2017-12-29FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals Inc.)
FDA approved Camber Pharmaceuticals' methylphenidate hydrochloride as a generic product under an original ANDA.
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FDA approval · 2017-12-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (SUNRISE PHARMACEUTICAL, INC.)
FDA approved Sunrise Pharmaceutical, Inc.'s generic fixed-dose combination of four amphetamine salts (dextroamphetamine saccharate, amphetam…
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FDA approval · 2017-11-16FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA entry documenting a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc. as part of the regulatory ap…