Attention Deficit Hyperactivity Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-10-18FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (SUNRISE PHARMACEUTICAL, INC.)
FDA approved Sunrise Pharmaceutical's generic dextroamphetamine sulfate under an original application (ANDA210059).
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FDA approval · 2017-07-31FDA Approved: VYVANSE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Vyvanse (lisdexamfetamine dimesylate) from Takeda Pharmaceuticals America, Inc., providing a…
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FDA approval · 2017-07-28FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Trigen Laboratories, LLC)
FDA approved an original application for methylphenidate hydrochloride from Trigen Laboratories, LLC.
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FDA approval · 2017-07-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII — Original Application (Alvogen Inc.)
FDA approves a generic combination tablet containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amp…
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FDA approval · 2017-07-05FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approves the original (ANDA) application for Dexmethylphenidate hydrochloride from Amneal Pharmaceuticals of New York LLC (generic ADHD …
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FDA approval · 2017-07-05FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's original application for dexmethylphenidate hydrochloride as a generic ADHD treatment, marking the first generic entry f…
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FDA approval · 2017-06-20FDA Approved: MYDAYIS — Original Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved the original application for MYDAYIS, a mixed amphetamine salts product, for the treatment of attention deficit hyperactivi…
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FDA approval · 2017-06-19FDA Approved: COTEMPLA XR-ODT — Original Application (Neos Therapeutics Brands, LLC)
The FDA approved Cotempla XR-ODT (methylphenidate) through an original NDA for the treatment of attention-deficit/hyperactivity disorder. Th…
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FDA approval · 2017-05-30FDA Approved: ATOMOXETINE — Original Application (Northstar Rx LLC)
FDA approved the original application for a generic atomoxetine product by Northstar Rx LLC.
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FDA approval · 2017-05-30FDA Approved: ATOMOXETINE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s original ANDA for atomoxetine, establishing a generic version of the ADHD medication.
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FDA approval · 2017-05-30FDA Approved: ATOMOXETINE HYDROCHLORIDE — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s generic atomoxetine hydrochloride as an original ANDA for the treatment of attention-deficit/hyperactivity disor…
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FDA approval · 2017-05-30FDA Approved: ATOMOXETINE — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original application for atomoxetine (generic). Atomoxetine is used to treat attention deficit hyper…
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FDA approval · 2017-05-19FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) submitted by Amneal Pharmaceuticals LLC.
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FDA approval · 2017-05-19FDA Approved: STRATTERA — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for Strattera (atomoxetine hydrochloride) filed by Eli Lilly and Company.
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FDA approval · 2017-05-12FDA Approved: DYANAVEL XR — Supplemental Application (NextWave Pharmaceuticals, Inc)
The FDA approved a supplemental application for DYANAVEL XR (amphetamine) submitted by NextWave Pharmaceuticals, Inc. The action concerns th…
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FDA approval · 2017-05-11FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (KVK-TECH, INC.)
FDA approved the original application for methylphenidate hydrochloride from KVK-Tech, Inc., granting a generic version of this stimulant fo…
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FDA approval · 2017-02-28FDA Approved: QUILLICHEW ER — Supplemental Application (NextWave Pharmaceuticals, Inc)
The FDA approved a supplemental application for QUILLICHEW ER (methylphenidate hydrochloride) by NextWave Pharmaceuticals, Inc., resulting i…
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FDA approval · 2017-02-01FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (KVK-Tech, Inc.)
FDA approved a supplemental application for Dextroamphetamine sulfate from KVK-Tech, Inc., under an ANDA. This action confirms approval of a…
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FDA approval · 2017-01-28FDA Approved: VYVANSE — Original Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved Vyvanse (lisdexamfetamine dimesylate) from Takeda as an original drug application (NDA 208510). It is approved for the trea…
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FDA approval · 2017-01-24FDA Approved: QUILLIVANT XR — Supplemental Application (NextWave Pharmaceuticals, Inc)
FDA approved a supplemental application for QUILLIVANT XR (methylphenidate hydrochloride) from NextWave Pharmaceuticals, Inc.
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FDA approval · 2017-01-06FDA Approved: VYVANSE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Vyvanse (lisdexamfetamine dimesylate) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2017-01-06FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (NorthStar RxLLC)
The FDA approved a supplemental ANDA for a generic combination of amphetamine salts (dextroamphetamine and amphetamine sulfates) from NorthS…
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FDA approval · 2017-01-06FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application from Prasco Laboratories for a generic combination of four amphetamine salts (dextroamphetamine …
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FDA approval · 2017-01-04FDA Approved: AMPHETAMINE EXTENDED-RELEASE — Supplemental Application (Neos Therapeutics, LP)
FDA approved a supplemental application for Amphetamine Extended-Release by Neos Therapeutics, LP under NDA 204326.
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FDA approval · 2017-01-04FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for FOCALIN XR (dexmethylphenidate hydrochloride) submitted by Sandoz Inc.