Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-02-25FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Solco Healthcare US, LLC)
FDA approved a supplemental application for Amphetamine Sulfate submitted by Solco Healthcare US, LLC. The approval pertains to the generic …
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FDA approval · 2022-02-25FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma LLC)
FDA approved a supplemental application for Amphetamine sulfate filed by Epic Pharma LLC.
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approves a supplemental application for a combination of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetam…
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Camber Pharmaceuticals’ generic product consisting of dextroamphetamine saccharate, amphetam…
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Elite Laboratories, Inc.)
FDA approves Elite Laboratories, Inc.'s supplemental application for a generic product containing four amphetamine salt components (dextroam…
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for dextroamphetamine sulfate from SpecGx LLC, approving a generic formulation of the ADHD/narcoleps…
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application from Sandoz to add salt forms of dextroamphetamine and amphetamine for a generic product (dextroamph…
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FDA approval · 2022-02-25FDA Approved: AMPHETAMINE EXTENDED-RELEASE — Supplemental Application (Neos Therapeutics, LP)
The FDA approved a supplemental application for Amphetamine Extended-Release from Neos Therapeutics, LP, representing an additional regulato…
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FDA approval · 2022-02-25FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for Amphetamine Sulfate submitted by Granules Pharmaceuticals Inc.
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Oryza Pharmaceuticals Inc.)
FDA approved a supplemental application for a generic mixed amphetamine salts product consisting of dextroamphetamine saccharate, amphetamin…
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved Cranbury Pharmaceuticals' supplemental application for dextroamphetamine (generic) under ANDA 203644, enabling the generic …
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application from Sun Pharmaceutical to market a generic product containing a combination of dextroamphetamine an…
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FDA approval · 2022-02-14FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA granted supplemental approval for Teva Pharmaceuticals USA, Inc. to market a generic combination product containing four amphetamine…
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FDA approval · 2022-02-14FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for the combination of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfat…
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FDA approval · 2022-02-10FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for Amphetamine Sulfate (amphetamine) by Amneal Pharmaceuticals NY LLC under ANDA211139, marking a r…
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FDA approval · 2022-02-09FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2022-02-09FDA Approved: XYWAV — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approved a supplemental application for XYWAV, the calcium, magnesium, potassium, and sodium oxybates product from Jazz Pharmaceuticals.…
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FDA approval · 2022-01-31FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva's generic combination of four amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroam…
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FDA approval · 2021-12-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved a new generic combination amphetamine product (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, …
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FDA approval · 2021-11-26FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Golden State Medical Supply, Inc.)
FDA approved a generic drug product comprising four amphetamine salts (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine …
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FDA approval · 2021-10-20FDA Approved: SUNOSI — Supplemental Application (Axsome Therapeutics, Inc.)
The FDA approval record concerns a supplemental application for Sunosi (solriamfetol) from Axsome Therapeutics, with the submission status s…
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FDA approval · 2021-09-29FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic product containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphe…
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FDA approval · 2021-08-12FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc., updating the product's regulatory ap…
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FDA approval · 2021-07-19FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)
FDA approved a supplemental application for MethyLin (methylphenidate hydrochloride) submitted by Shionogi under NDA 021419.
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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.