Attention Deficit Hyperactivity Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-06-25FDA Approved: COTEMPLA XR-ODT — Supplemental Application (Neos Therapeutics Brands, LLC)
The FDA approved a supplemental application for Cotempla XR-ODT (methylphenidate) by Neos Therapeutics Brands, LLC, for the treatment of att…
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FDA approval · 2021-06-25FDA Approved: JORNAY PM EXTENDED-RELEASE — Supplemental Application (Ironshore Pharmaceuticals Inc.)
FDA approved a supplemental application for Jornay PM Extended-Release (methylphenidate hydrochloride) from Ironshore Pharmaceuticals Inc.
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FDA approval · 2021-06-25FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
The FDA approved a supplemental application for methylphenidate hydrochloride submitted by Granules Pharmaceuticals Inc.
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FDA approval · 2021-06-25FDA Approved: APTENSIO XR — Supplemental Application (Rhodes Pharmaceuticals L.P.)
The FDA approved a supplemental application for Aptensio XR (methylphenidate hydrochloride) from Rhodes Pharmaceuticals L.P.
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FDA approval · 2021-06-25FDA Approved: QUILLICHEW ER — Supplemental Application (NextWave Pharmaceuticals, Inc)
The FDA approved a supplemental application for Quillichew ER (methylphenidate hydrochloride) submitted by NextWave Pharmaceuticals, Inc.
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FDA approval · 2021-06-25FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals Inc.)
FDA approves Camber Pharmaceuticals' supplemental application for methylphenidate hydrochloride tablets, providing a new generic option.
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FDA approval · 2021-06-25FDA Approved: METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (KVK-Tech, Inc.)
FDA granted supplemental approval for a generic extended-release methylphenidate hydrochloride product from KVK-Tech, Inc.
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FDA approval · 2021-06-25FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride by Rising Pharma Holdings, Inc., effectively authorizing a generic…
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FDA approval · 2021-06-22FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for methylphenidate hydrochloride from Rising Pharma Holdings, Inc., signaling an approved suppl…
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FDA approval · 2021-06-21FDA Approved: METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (KVK-Tech, Inc.)
The FDA approved a supplemental application for methylphenidate hydrochloride extended-release from KVK-Tech, Inc., authorizing changes to t…
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FDA approval · 2021-06-14FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methylphenidate hydrochloride from SpecGx LLC.
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FDA approval · 2021-04-22FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic product containing four amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate,…
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FDA approval · 2021-04-02FDA Approved: QELBREE — Original Application (Supernus Pharmaceuticals, Inc)
FDA approved QELBREE (viloxazine hydrochloride) through an original NDA from Supernus Pharmaceuticals, Inc. for the treatment of attention-d…
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FDA approval · 2021-03-11FDA Approved: ATOMOXETINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original application for atomoxetine, enabling the marketing of a generic atomoxetine product.
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FDA approval · 2021-03-09FDA Approved: ATOMOXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application from Apotex Corp. to market a generic atomoxetine hydrochloride product.
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FDA approval · 2021-03-03FDA Approved: GUANFACINE HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a generic formulation of guanfacine hydrochloride under an Original Application (ANDA 214689) for Unichem Pharmaceuticals (USA)…
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FDA approval · 2021-03-02FDA Approved: AZSTARYS — Original Application (Corium, LLC.)
The FDA approved AZSTARYS, a once-daily ADHD medication containing serdexmethylphenidate and dexmethylphenidate, from Corium, LLC, under an …
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FDA approval · 2021-02-18FDA Approved: ATOMOXETINE — Original Application (Strides Pharma Science Limited)
FDA approved an original application for generic atomoxetine by Strides Pharma Science Limited, enabling generic atomoxetine products in the…
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FDA approval · 2021-01-29FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Ascent Pharmaceuticals, Inc.)
FDA approved a generic methylphenidate hydrochloride product under an Original Application (ANDA 207417) from Ascent Pharmaceuticals, Inc. f…
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FDA approval · 2021-01-22FDA Approved: AMPHETAMINE SULFATE — Original Application (SpecGx LLC)
FDA approved the Original Application for amphetamine sulfate as a generic drug, filed by SpecGx LLC.
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FDA approval · 2021-01-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Rhodes Pharmaceuticals L.P.)
FDA approves Rhodes Pharmaceuticals' original ANDA for a four-salt generic amphetamine product indicated for attention-deficit/hyperactivity…
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FDA approval · 2020-11-25FDA Approved: GUANFACINE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approved Slate Run Pharmaceuticals’ guanfacine as a generic product via an Original Application (ANDA213428).
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FDA approval · 2020-10-29FDA Approved: GUANFACINE EXTENDED-RELEASE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for guanfacine extended-release by Apotex Corp., enabling a generic version of the ADHD medication.
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FDA approval · 2020-10-28FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Accord Healthcare, Inc.)
The FDA approved Accord Healthcare's generic methylphenidate hydrochloride under Original Application (ANDA213936) for the treatment of atte…
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FDA approval · 2020-10-27FDA Approved: AMPHETAMINE SULFATE — Original Application (Epic Pharma LLC)
FDA approved the Original Application for amphetamine sulfate as a generic drug manufactured by Epic Pharma LLC (ANDA 213980).