Attention Deficit Hyperactivity Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-10-13FDA Approved: AZSTARYS — Supplemental Application (Corium, LLC.)
The FDA approved a supplemental application for AZSTARYS (serdexmethylphenidate and dexmethylphenidate) from Corium, LLC.
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' supplemental application for a generic combination product containing four amphetamine salts: dextroamp…
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for a combination amphetamine/dextroamphetamine product from Granules Pharmaceuticals Inc. containin…
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Supplemental Application (Neolpharma, Inc.)
FDA approved a supplemental application for a generic combination of dextroamphetamine and amphetamine salts manufactured by Neolpharma, Inc…
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved a supplemental application for dextroamphetamine sulfate (generic) from Cranbury Pharmaceuticals, enabling the marketing of…
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FDA approval · 2023-10-13FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)
FDA approved a supplemental NDA for the methylphenidate transdermal system, sponsored by PADAGIS US LLC.
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FDA approval · 2023-10-13FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)
The FDA approved a supplemental application for CONCERTA (methylphenidate hydrochloride) from Janssen Pharmaceuticals, Inc. The approval upd…
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FDA approval · 2023-10-13FDA Approved: EVEKEO — Supplemental Application (Azurity Pharmaceuticals, Inc.)
FDA approved a supplemental application for EVEKEO (amphetamine sulfate) submitted by Azurity Pharmaceuticals, Inc.
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FDA approval · 2023-10-13FDA Approved: QUILLIVANT XR — Supplemental Application (NextWave Pharmaceuticals, Inc)
The FDA approved a supplemental application for QUILLIVANT XR (methylphenidate hydrochloride) from NextWave Pharmaceuticals, Inc. The docume…
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FDA approval · 2023-10-13FDA Approved: MYDAYIS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for MYDAYIS (mixed amphetamine salts) from Takeda, updating the drug’s labeling per the supplemental…
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FDA approval · 2023-10-13FDA Approved: DYANAVEL XR — Supplemental Application (NextWave Pharmaceuticals, Inc)
FDA approved a supplemental NDA for DYANAVEL XR (amphetamine) submitted by NextWave Pharmaceuticals, Inc.
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FDA approval · 2023-10-13FDA Approved: XELSTRYM — Supplemental Application (Noven Therapeutics, LLC)
FDA approved a supplemental application for XELSTRYM (dextroamphetamine) from Noven Therapeutics, LLC. The snippet does not specify the exac…
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FDA approval · 2023-10-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Trigen Laboratories, LLC)
FDA approved a supplemental application for methylphenidate hydrochloride from Trigen Laboratories, LLC.
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application from Sun Pharmaceutical Industries for a generic product comprising four amphetamine salt compon…
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FDA approval · 2023-10-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride from Camber Pharmaceuticals Inc., confirming approval of a generic…
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Wilshire Pharmaceuticals, Inc.)
FDA approved a supplemental application for dextroamphetamine sulfate by Wilshire Pharmaceuticals, Inc.
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FDA approval · 2023-10-11FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for Amphetamine Sulfate (amphetamine) from Amneal Pharmaceuticals NY LLC under ANDA211139.
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FDA approval · 2023-10-05FDA Approved: GUANFACINE — Original Application (A2A Integrated Pharmaceuticals)
FDA approved the original application for guanfacine from A2A Integrated Pharmaceuticals, enabling generic guanfacine products to enter the …
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FDA approval · 2023-09-27FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's original ANDA for a generic mixture of dextroamphetamine and amphetamine salts (dextroamphetamine sacchara…
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FDA approval · 2023-09-12FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for methylphenidate hydrochloride, resulting in an approved modification to th…
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FDA approval · 2023-09-12FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Eywa Pharma Inc)
FDA approved Eywa Pharma Inc's supplemental application for methylphenidate hydrochloride.
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FDA approval · 2023-09-07FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for methylphenidate hydrochloride from Sun Pharmaceutical Industries, authorizing modifications …
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FDA approval · 2023-08-31FDA Approved: MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE PRODUCT — Original Application (SpecGx LLC)
FDA approved an original ANDA for a mixed-salts amphetamine product by SpecGx LLC, comprising multiple dextroamphetamine/amphetamine salts.
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FDA approval · 2023-08-25FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' lisdexamfetamine dimesylate as an original-application generic product under ANDA 217068.
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FDA approval · 2023-08-25FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
The FDA approved a supplemental application from Granules Pharmaceuticals Inc. for dexmethylphenidate hydrochloride granules, expanding the …