Attention Deficit Hyperactivity Disorder
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2026-04-23FDA Approved: VYVANSE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Vyvanse to update its labeling (indications/usage) following regulatory action.
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FDA label_change · 2024-03-12FDA Approved: AMPHETAMINE EXTENDED-RELEASE — Supplemental Application (Neos Therapeutics, LP)
The FDA approved a supplemental application for AMPHETAMINE EXTENDED-RELEASE by Neos Therapeutics, LP.
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FDA label_change · 2024-01-17FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for lisdexamfetamine dimesylate from Hikma Pharmaceuticals USA Inc., resulting in changes to the pro…
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FDA label_change · 2023-10-13FDA 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 label_change · 2023-10-13FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) submitted by Amneal Pharmaceuticals LLC. This…
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FDA label_change · 2022-01-06FDA Approved: STRATTERA — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for Strattera (atomoxetine hydrochloride) from Eli Lilly and Company, updating the drug's labeli…
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FDA label_change · 2021-06-25FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)
FDA announces a supplemental application outcome for METHYLIN (methylphenidate hydrochloride) from Shionogi Inc., resulting in a labeling ch…
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FDA label_change · 2019-11-19FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc, resulting in labeling changes for the product.
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FDA label_change · 2019-01-10FDA Approved: FOCALIN — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for FOCALIN from Sandoz Inc, updating the product labeling based on the submitted supplement.
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FDA label_change · 2017-01-04FDA Approved: QUILLICHEW ER — Supplemental Application (NextWave Pharmaceuticals, Inc)
FDA approved a supplemental application for Quillichew ER (methylphenidate hydrochloride) from NextWave Pharmaceuticals, resulting in update…
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FDA label_change · 2017-01-04FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)
FDA approved a supplemental application for METHYLIN (methylphenidate hydrochloride) submitted by Shionogi Inc., resulting in a labeling upd…
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FDA label_change · 2015-12-04FDA Approved: FOCALIN — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for FOCALIN (dexmethylphenidate hydrochloride) submitted by Sandoz Inc, resulting in a label cha…
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FDA label_change · 2015-10-13FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for clonidine hydrochloride by Actavis Pharma, Inc., indicating changes to the approved product …
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FDA label_change · 2015-05-06FDA Approved: GUANFACINE — Supplemental Application (PuraCap Laboratories LLC dba Blu Pharmaceuticals)
FDA approved a supplemental application for guanfacine from PuraCap Laboratories dba Blu Pharmaceuticals.
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FDA label_change · 2014-07-14FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) filed by Novartis Pharmaceuticals Corporation, resul…
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FDA label_change · 2014-03-29FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for dextroamphetamine sulfate from Teva Pharmaceuticals USA, Inc., resulting in updated labeling…
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FDA label_change · 2014-02-21FDA Approved: STRATTERA — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for STRATTERA (atomoxetine hydrochloride) from Eli Lilly and Company. The action updates the product…
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FDA label_change · 2013-12-12FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)
The FDA approved a supplemental application for METHYLIN (methylphenidate hydrochloride) submitted by Shionogi Inc. The approval updates the…
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FDA label_change · 2013-06-14FDA Approved: VYVANSE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Vyvanse to update the product labeling.
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FDA label_change · 2013-06-14FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)
FDA approved a supplemental application for Methylin (methylphenidate hydrochloride) from Shionogi Inc., indicating a labeling change for th…
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FDA label_change · 2013-06-11FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) from Amneal Pharmaceuticals LLC, resulting in cha…
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FDA label_change · 2012-07-05FDA Approved: STRATTERA — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for STRATTERA (atomoxetine hydrochloride) from Eli Lilly and Company, updating labeling.
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FDA label_change · 2010-12-09FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) submitted by Novartis, resulting in updated labeling for…
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FDA label_change · 2006-08-24FDA Approved: FOCALIN — Supplemental Application (Sandoz Inc)
FDA approves a supplemental application for FOCALIN (dexmethylphenidate hydrochloride) from Sandoz Inc, resulting in changes to the drug's l…