Attention Deficit Hyperactivity Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-08-22FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Par Health USA, LLC)
The FDA approved a supplemental application for dexmethylphenidate hydrochloride extended-release, confirming regulatory approval for this e…
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FDA approval · 2014-07-24FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for a product containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine …
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FDA approval · 2014-07-18FDA Approved: VYVANSE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Vyvanse (lisdexamfetamine dimesylate) submitted by Takeda Pharmaceuticals America, Inc. The acti…
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FDA approval · 2014-06-10FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Teva's generic fixed-dose combination of amphetamine salts (dextroamphetamine saccharate, amphet…
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FDA approval · 2014-05-19FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's generic dexmethylphenidate hydrochloride under an original ANDA, expanding treatment options for attention-deficit/hyper…
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FDA approval · 2014-05-19FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's generic dexmethylphenidate hydrochloride under an original ANDA (ANDA 078908) for the treatment of attention-deficit…
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FDA approval · 2014-05-19FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved Amneal Pharmaceuticals of New York LLC's original application for dexmethylphenidate hydrochloride as a generic treatment f…
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FDA approval · 2014-03-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for a generic product consisting of four amphetamine salt components: dextroamphetamine saccharate, …
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FDA approval · 2014-03-12FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a generic methylphenidate hydrochloride product from Amneal Pharmaceuticals of New York LLC under an Original Application, …
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FDA approval · 2014-02-20FDA 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 · 2014-02-19FDA Approved: GUANFACINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application to authorize a generic guanfacine hydrochloride product from Amneal Pharmaceuticals of New York LLC.…
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FDA approval · 2014-02-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental application for a generic combination of amphetamine salts (dextroamphetamine saccharate, amphetamine a…
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FDA approval · 2014-02-07FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2014-01-28FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for Dexmethylphenidate hydrochloride, a generic ADHD medication. This action confirms approval …
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FDA approval · 2014-01-22FDA Approved: METHYLPHENIDATE HYDROCHLORIDE (LA) — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approved a supplemental application for methylphenidate hydrochloride extended-release (LA) submitted by Dr. Reddy's Laboratories Inc.
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FDA approval · 2014-01-22FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for a generic dexmethylphenidate hydrochloride product from Amneal Pharmaceuticals, enabling continu…
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FDA approval · 2014-01-22FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)
FDA approves a supplemental ANDA for a combination of amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate monohydrate, de…
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FDA approval · 2014-01-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical Industries' supplemental application for methylphenidate hydrochloride. The approval pertains to a labeling …
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FDA approval · 2013-12-31FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)
The FDA approved a supplemental application for Epic Pharma's generic combination of amphetamine salts (dextroamphetamine saccharate, amphet…
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FDA approval · 2013-12-31FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride (generic) from Lannett Company, Inc., confirming regulatory approv…
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FDA approval · 2013-12-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for a generic methylphenidate hydrochloride CD product by Lannett Company, expanding the availab…
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FDA approval · 2013-12-13FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2013-12-13FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental NDA for methylphenidate from Sandoz Inc.
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FDA approval · 2013-12-12FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)
FDA approved a supplemental application for the Methylphenidate Transdermal System from Padagis US LLC. This action expands the product's la…
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FDA approval · 2013-12-12FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)
The FDA approved a supplemental application for CONCERTA (methylphenidate hydrochloride) submitted by Janssen Pharmaceuticals, Inc.