Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-03-28FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for methylphenidate hydrochloride, a generic stimulant product, enabling it…
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FDA approval · 2024-03-08FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (KVK-Tech, Inc.)
FDA approved a supplemental application for dextroamphetamine sulfate from KVK-Tech, Inc., making the generic product available via an appro…
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FDA approval · 2024-02-28FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride from Sun Pharmaceutical Industries, expanding the approval status …
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FDA approval · 2024-02-27FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Eywa Pharma Inc)
FDA approves Eywa Pharma Inc's supplemental application for methylphenidate hydrochloride, a generic ADHD medication, under an ANDA.
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FDA approval · 2024-02-27FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for Granules Pharmaceuticals' combination amphetamine salts product (dextroamphetamine saccharate, a…
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FDA approval · 2024-02-27FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application from Granules Pharmaceuticals Inc. for a generic product containing four amphetamine/dextroamphetami…
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FDA approval · 2024-01-26FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (NorthStar RxLLC)
FDA approved NorthStar RxLLC's supplemental application for a generic four-salt amphetamine/dextroamphetamine product (dextroamphetamine sac…
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FDA approval · 2024-01-26FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Oryza Pharmaceuticals Inc.)
FDA approved a supplemental application for a generic product containing four amphetamine salts (dextroamphetamine saccharate, amphetamine a…
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FDA approval · 2024-01-16FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Sodium Oxybate submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2024-01-16FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Aurolife Pharma, LLC)
FDA approved a supplemental application for amphetamine sulfate manufactured by Aurolife Pharma, LLC.
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FDA approval · 2024-01-11FDA 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 · 2023-10-31FDA Approved: LUMRYZ — Supplemental Application (Avadel CNS Pharmaceuticals, LLC)
FDA approved a supplemental application for LUMRYZ (sodium oxybate) from Avadel CNS Pharmaceuticals, LLC to support its use for narcolepsy.
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FDA approval · 2023-10-20FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII — Supplemental Application (Alvogen Inc.)
FDA approves Alvogen Inc.'s supplemental application to market generic mixed amphetamine salts tablets (dextroamphetamine/amphetamines) in m…
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FDA approval · 2023-10-20FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for methylphenidate hydrochloride (generic). This approval supports the ava…
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FDA approval · 2023-10-20FDA Approved: DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application from SpecGx LLC for a generic product containing dextroamphetamine saccharate and amphetamine aspart…
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FDA approval · 2023-10-18FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Solco Healthcare US, LLC)
FDA approved a supplemental application for Amphetamine Sulfate from Solco Healthcare US, LLC.
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FDA approval · 2023-10-18FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for Rhodes Pharmaceuticals L.P. for a four-ingredient amphetamine product (dextroamphetamine sacchar…
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FDA approval · 2023-10-17FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for Amphetamine sulfate from Granules Pharmaceuticals Inc. to support a formulation change to a gran…
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FDA approval · 2023-10-16FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for amphetamine sulfate (Amneal Pharmaceuticals NY LLC), resulting in an updated regulatory approval…
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application from Prasco Laboratories for a four-salt combination product containing dextroamphetamine saccharate…
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FDA approval · 2023-10-13FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)
FDA approved a supplemental application for METHYLIN (methylphenidate hydrochloride) from Shionogi Inc., potentially updating the label or i…
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FDA approval · 2023-10-13FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate (Sandoz Inc) to update the product labeling under the NDA.
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FDA approval · 2023-10-13FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) from Novartis Pharmaceuticals Corporation.
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for dextroamphetamine sulfate (generic).
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application by Teva for a four-salt amphetamine product consisting of dextroamphetamine saccharate, amphetamine …