Attention Deficit Hyperactivity Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-01-23FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for lisdexamfetamine dimesylate from Camber Pharmaceuticals, enabling its generic product to be …
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FDA approval · 2025-01-23FDA Approved: QELBREE — Supplemental Application (Supernus Pharmaceuticals, Inc)
The FDA approved a supplemental application for QELBREE (viloxazine hydrochloride) from Supernus Pharmaceuticals.
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FDA approval · 2025-01-15FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for a generic dexmethylphenidate hydrochloride product from Camber Pharmaceuticals, expanding its re…
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FDA approval · 2024-12-23FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Method Pharmaceuticals, LLC)
FDA approved a supplemental application for clonidine hydrochloride submitted by Method Pharmaceuticals, LLC.
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FDA approval · 2024-12-17FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals, Inc.)
FDA approved a Teva supplemental application for a generic combination of four amphetamine salts (dextroamphetamine saccharate, amphetamine …
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FDA approval · 2024-12-17FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for Dexmethylphenidate hydrochloride (Amneal) to approve a generic version of the ADHD medication.
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FDA approval · 2024-12-17FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application from Granules Pharmaceuticals Inc. for methylphenidate hydrochloride granules, adding a new dosage f…
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FDA approval · 2024-12-17FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Original Application (SpecGx LLC)
FDA approved lisdexamfetamine dimesylate as a generic version of Vyvanse under an Original Application (ANDA) from SpecGx LLC. The product i…
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FDA approval · 2024-12-16FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals Inc.'s original application for lisdexamfetamine dimesylate, a generic version of the ADHD medication,…
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FDA approval · 2024-11-29FDA Approved: XELSTRYM — Supplemental Application (Noven Therapeutics, LLC)
FDA approved a supplemental application for XELSTRYM (dextroamphetamine) by Noven Therapeutics, LLC.
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FDA approval · 2024-11-29FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)
FDA approved the supplemental application for the Methylphenidate Transdermal System (methylphenidate) from PADAGIS US LLC. This action upda…
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FDA approval · 2024-11-19FDA Approved: GUANFACINE — Original Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved the original application for generic guanfacine from Unichem Pharmaceuticals (USA), Inc.
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FDA approval · 2024-11-15FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Original Application (Elite Laboratories, Inc.)
FDA approved the original application for lisdexamfetamine dimesylate as a generic product from Elite Laboratories, Inc., confirming regulat…
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FDA approval · 2024-10-25FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for lisdexamfetamine dimesylate (ANDA 217068), allowing marketing of a generic…
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FDA approval · 2024-10-25FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma, Inc.'s supplemental application for dextroamphetamine sulfate, confirming continued approval and updating label…
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FDA approval · 2024-10-07FDA Approved: METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methylphenidate hydrochloride extended-release (SpecGx LLC). This action represents the approval…
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FDA approval · 2024-10-01FDA Approved: METHYLPHENIDATE HYDROCHLORIDE (LA) — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Teva's long-acting methylphenidate hydrochloride product. This action confirms regulatory author…
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FDA approval · 2024-09-25FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for lisdexamfetamine dimesylate (generic) submitted by SpecGx LLC under ANDA 211840.
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FDA approval · 2024-09-16FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's supplemental application to market lisdexamfetamine dimesylate as a generic drug, expanding access…
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FDA approval · 2024-09-16FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)
The FDA approved a supplemental application for lisdexamfetamine dimesylate from Teva Pharmaceuticals under an ANDA, approving changes to th…
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FDA approval · 2024-09-10FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (KVK-TECH, INC)
FDA approved a supplemental application for Dexmethylphenidate hydrochloride from KVK-Tech, Inc., granting approval of a generic product und…
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FDA approval · 2024-09-10FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)
FDA approved a supplemental application for a generic Dexmethylphenidate hydrochloride product from Nivagen Pharmaceuticals, expanding acces…
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FDA approval · 2024-09-09FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for dexmethylphenidate hydrochloride, signaling approval of a generi…
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FDA approval · 2024-08-30FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for a four-salt amphetamine combination (dextroamphetamine saccharate, amphetamine aspartate monohyd…
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FDA approval · 2024-08-30FDA Approved: METHYLPHENIDATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for methylphenidate submitted by Mylan Pharmaceuticals Inc. The approval covers the changes describe…