Attention Deficit Hyperactivity Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2013-12-12FDA Approved: QUILLIVANT XR — Supplemental Application (NextWave Pharmaceuticals, Inc)
The FDA approved a supplemental application for QUILLIVANT XR (methylphenidate hydrochloride) from NextWave Pharmaceuticals, under NDA 20210…
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FDA approval · 2013-12-12FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for FOCALIN XR, submitted by Sandoz Inc, indicating an approved modification to the product’s labeli…
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FDA approval · 2013-12-12FDA Approved: FOCALIN — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for FOCALIN (dexmethylphenidate hydrochloride) submitted by Sandoz Inc.
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FDA approval · 2013-12-04FDA Approved: STRATTERA — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for Strattera (atomoxetine hydrochloride) submitted by Eli Lilly and Company.
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FDA approval · 2013-12-03FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for a four-salt dextroamphetamine/amphetamine product manufactured by Prasco Laboratories.
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FDA approval · 2013-11-27FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (NorthStar RxLLC)
FDA approved NorthStar RxLLC's generic mixed amphetamine salts product (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetami…
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FDA approval · 2013-11-21FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approved the original ANDA for dexmethylphenidate hydrochloride from Amneal Pharmaceuticals of New York LLC, establishing a generic opti…
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FDA approval · 2013-11-19FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved the original application for dexmethylphenidate hydrochloride as a generic product, expanding availability of this ADHD medicat…
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FDA approval · 2013-11-19FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a generic dexmethylphenidate hydrochloride product from Teva under an original application for the treatment of attention-d…
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FDA approval · 2013-11-18FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE — Original Application (Par Health USA, LLC)
FDA approved the original application for a generic dexmethylphenidate hydrochloride extended-release product from Par Health USA, LLC, for …
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FDA approval · 2013-10-25FDA 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 · 2013-09-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for a generic fixed-combination amphetamine product containing dextroamphetamine saccharate, am…
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FDA approval · 2013-09-23FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lannett Company, Inc.)
The FDA approved Lannett Company's original application for methylphenidate hydrochloride, enabling the marketing of a generic methylphenida…
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FDA approval · 2013-09-19FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved a supplemental application for methylphenidate hydrochloride submitted by Cranbury Pharmaceuticals, LLC. The approval confi…
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FDA approval · 2013-08-23FDA Approved: INTUNIV — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Intuniv (guanfacine) from Takeda Pharmaceuticals America, Inc., updating the label for its u…
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FDA approval · 2013-08-09FDA Approved: QUILLIVANT XR — Supplemental Application (NextWave Pharmaceuticals, Inc)
The FDA approved a supplemental application for QUILLIVANT XR (methylphenidate hydrochloride) from NextWave Pharmaceuticals, expanding the r…
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FDA approval · 2013-08-07FDA Approved: ATOMOXETINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for atomoxetine by Zydus Pharmaceuticals USA Inc., marking an approved change to this generic ADHD m…
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FDA approval · 2013-08-05FDA Approved: STRATTERA — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for STRATTERA (atomoxetine hydrochloride) filed by Eli Lilly and Company to update the product l…
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FDA approval · 2013-07-31FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (Aurolife Pharma, LLC)
FDA approved Aurolife Pharma, LLC's dextroamphetamine sulfate as an original-application generic, authorizing a generic stimulant for attent…
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FDA approval · 2013-07-30FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for CONCERTA (methylphenidate hydrochloride) submitted by Janssen Pharmaceuticals, Inc.
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FDA approval · 2013-07-09FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lannett Company, Inc.)
FDA approved the original ANDA for a generic methylphenidate hydrochloride product by Lannett Company, Inc.
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FDA approval · 2013-06-14FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental NDA for a four-salt amphetamine product (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextro…
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FDA approval · 2013-06-12FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for CONCERTA (methylphenidate hydrochloride) from Janssen Pharmaceuticals, Inc.
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FDA approval · 2013-06-11FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for FOCALIN XR submitted by Sandoz Inc., involving dexmethylphenidate hydrochloride.
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FDA approval · 2013-06-07FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc.