Attention Deficit Hyperactivity Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-01-15FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) from Amneal Pharmaceuticals LLC.
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FDA approval · 2019-01-10FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for FOCALIN XR (dexmethylphenidate hydrochloride) submitted by Sandoz Inc.
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FDA approval · 2019-01-10FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate from Sandoz Inc, supporting continued marketing of the product.
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FDA approval · 2018-12-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma, Inc.'s methylphenidate hydrochloride generic under an original application (ANDA 208861).
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FDA approval · 2018-12-07FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Elite Laboratories, Inc.)
FDA approved Elite Laboratories, Inc.'s original ANDA for a combination amphetamine product consisting of dextroamphetamine saccharate, amph…
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FDA approval · 2018-11-21FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals Inc.'s methylphenidate hydrochloride generic under an original ANDA.
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FDA approval · 2018-10-12FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)
FDA approved Somerset Therapeutics' clonidine hydrochloride as a generic drug under an Original Application. The approval supports the gener…
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FDA approval · 2018-10-09FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE — Original Application (Lannett Company, Inc.)
FDA approved the original application for a generic dexmethylphenidate hydrochloride extended-release product from Lannett Company, Inc., es…
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FDA approval · 2018-10-03FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Eywa Pharma Inc)
FDA approved Eywa Pharma Inc's methylphenidate hydrochloride under an original ANDA, adding a generic option for ADHD treatment.
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FDA approval · 2018-09-26FDA Approved: AMPHETAMINE SULFATE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's generic amphetamine sulfate under an Original Application, enabling a generic version of this s…
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FDA approval · 2018-09-19FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Nivagen Pharmaceuticals, Inc.)
FDA approved the original ANDA for a generic dexmethylphenidate hydrochloride product manufactured by Nivagen Pharmaceuticals, Inc., for the…
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FDA approval · 2018-08-08FDA Approved: JORNAY PM EXTENDED-RELEASE — Original Application (Ironshore Pharmaceuticals Inc.)
FDA approved Jornay PM Extended-Release (methylphenidate hydrochloride) under an original NDA by Ironshore Pharmaceuticals for the treatment…
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FDA approval · 2018-07-25FDA Approved: GUANFACINE EXTENDED-RELEASE — Original Application (Apotex Corp.)
FDA approved Guanfacine Extended-Release from Apotex Corp. as an original application generic. Guanfacine extended-release is used to treat …
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FDA approval · 2018-07-16FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
The FDA has approved a supplemental application from Prasco Laboratories for a mixed salt formulation of dextroamphetamine and amphetamine (…
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FDA approval · 2018-03-23FDA Approved: METHYLPHENIDATE HYDROCHLORIDE (LA) — Supplemental Application (Dr. Reddy's Laboratories Inc)
The FDA approved a supplemental application for methylphenidate hydrochloride (LA) from Dr. Reddy's Laboratories Inc. to update/permit the e…
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FDA approval · 2018-03-22FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma, Inc.'s original ANDA for methylphenidate hydrochloride, establishing a generic version of the stimulant used to…
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FDA approval · 2018-03-21FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)
FDA approved the generic methylphenidate hydrochloride from Actavis Pharma under an original ANDA (ANDA076655).
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FDA approval · 2018-03-07FDA Approved: INTUNIV — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Intuniv (guanfacine) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2018-02-26FDA Approved: METHYLPHENIDATE HYDROCHLORIDE (LA) — Original Application (Dr. Reddy's Laboratories Inc)
FDA approved the original ANDA for methylphenidate hydrochloride (LA) from Dr. Reddy's Laboratories Inc., a generic long-acting formulation …
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FDA approval · 2018-02-23FDA Approved: ATOMOXETINE — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved an original ANDA for atomoxetine, a non-stimulant medication used to treat attention-deficit/hyperactivity disorder, with Dr. R…
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FDA approval · 2017-12-29FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals Inc.)
FDA approved Camber Pharmaceuticals' methylphenidate hydrochloride as a generic product under an original ANDA.
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FDA approval · 2017-12-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (SUNRISE PHARMACEUTICAL, INC.)
FDA approved Sunrise Pharmaceutical, Inc.'s generic fixed-dose combination of four amphetamine salts (dextroamphetamine saccharate, amphetam…
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FDA approval · 2017-11-20FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (Xiamen LP Pharmaceutical Co., Ltd.)
FDA approves the original application for clonidine hydrochloride from Xiamen LP Pharmaceutical Co., Ltd., granting a generic version of the…
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FDA approval · 2017-11-20FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (BluePoint Laboratories)
FDA approved an original abbreviated new drug application for a generic clonidine hydrochloride product from BluePoint Laboratories.
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FDA approval · 2017-11-06FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)
The FDA approved a supplemental application for the methylphenidate transdermal system (methylphenidate patch) submitted by PADAGIS US LLC.