Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-06-21FDA Approved: MODAFINIL — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for a generic modafinil product (ANDA077667), enabling its marketing in the United Stat…
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FDA approval · 2023-05-01FDA Approved: LUMRYZ — Original Application (Avadel CNS Pharmaceuticals, LLC)
FDA approved LUMRYZ (sodium oxybate) from Avadel CNS Pharmaceuticals, LLC as an original application (NDA214755) for the treatment of narcol…
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FDA approval · 2023-03-07FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Teva's generic amphetamine salt product, adding four amphetamine salt components (dextroamphetam…
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FDA approval · 2023-02-22FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for Granules Pharmaceuticals' generic four-salt amphetamine combination (dextroamphetamine saccharat…
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FDA approval · 2023-02-07FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application from Sandoz Inc for a generic product containing four amphetamine salts (dextroamphetamine saccharat…
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FDA approval · 2023-01-23FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals' generic combination amphetamine product containing dextroamphetamine saccharate, amphetamine aspartat…
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FDA approval · 2022-12-22FDA Approved: WAKIX — Supplemental Application (Harmony Biosciences, LLC)
The FDA approved a supplemental application for Wakix (pitolisant hydrochloride) submitted by Harmony Biosciences, LLC.
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FDA approval · 2022-12-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' supplemental application for methylphenidate hydrochloride (generic). This approval authorizes the manufac…
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FDA approval · 2022-12-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Neolpharma, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride (Neolpharma, Inc.) under an ANDA, granting regulatory approval for…
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FDA approval · 2022-11-30FDA Approved: MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Mixed Salts of a Single Entity Amphetamine Product XR, a generic extended-release amphetamine pr…
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FDA approval · 2022-09-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceutical Inc)
FDA approved Camber Pharmaceutical Inc.'s supplemental application for methylphenidate hydrochloride (generic) under an Abbreviated New Drug…
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FDA approval · 2022-09-06FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved a supplemental application for methylphenidate hydrochloride (generic product) from Cranbury Pharmaceuticals, LLC. This app…
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FDA approval · 2022-08-22FDA Approved: XYWAV — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approved a supplemental application for XYWAV (calcium, magnesium, potassium, and sodium oxybates) from Jazz Pharmaceuticals. This perta…
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FDA approval · 2022-08-22FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for sodium oxybate filed by Hikma Pharmaceuticals USA Inc. for its narcolepsy treatment product.
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FDA approval · 2022-08-18FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (Cranbury Pharmaceuticals, LLC)
FDA has approved Cranbury Pharmaceuticals' original application for a generic dextroamphetamine sulfate product. The approval covers its use…
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FDA approval · 2022-07-08FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Lannett Company, Inc.)
FDA approved Lannett's generic combination of four amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine…
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FDA approval · 2022-07-05FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Original Application (Neolpharma, Inc.)
FDA approved an original application for a generic product containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine…
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FDA approval · 2022-03-14FDA Approved: METHYLPHENIDATE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved a generic methylphenidate product (Original Application) from Mylan Pharmaceuticals Inc., for conditions such as ADHD and narco…
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FDA approval · 2022-02-25FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) by Amneal Pharmaceuticals LLC.
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for dextroamphetamine sulfate from Prasco Laboratories under ANDA 040776, marking an approved modifi…
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (NorthStar RxLLC)
FDA approves a supplemental application from NorthStar RxLLC for a generic combination of four amphetamine salts (dextroamphetamine sacchara…
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for dextroamphetamine sulfate, a generic stimulant used to treat attention-…
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII — Supplemental Application (Alvogen Inc.)
FDA approved a supplemental application for Alvogen's mixed amphetamine salts tablets (CII) in multiple strengths, expanding the generic pro…
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FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SUNRISE PHARMACEUTICAL, INC.)
FDA approved a supplemental application for a generic product containing four amphetamine salts (dextroamphetamine saccharate, amphetamine a…
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FDA approval · 2022-02-25FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (DR. REDDY'S LABORATORIES INC)
FDA approved a supplemental application for Amphetamine sulfate tablets from Dr. Reddy's Laboratories, indicating regulatory approval associ…