Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)
FDA approves Epic Pharma, LLC's supplemental application for a generic product containing dextroamphetamine saccharate, amphetamine aspartat…
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FDA approval · 2023-10-13FDA 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 combination product containing four amphetamine salts (dextroamphetami…
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
FDA approved a supplemental application for a generic dextr oamphetamine sulfate product from Lupin Pharmaceuticals, authorizing its continu…
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FDA approval · 2023-10-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride from Rising Pharma Holdings, Inc., authorizing its continued marke…
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (SUNRISE PHARMACEUTICAL, INC.)
The FDA approved a supplemental application for dextroamphetamine sulfate submitted by Sunrise Pharmaceutical, Inc.
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SUNRISE PHARMACEUTICAL, INC.)
The FDA approved Sunrise Pharmaceutical's supplemental application for a four-salt amphetamine product (dextroamphetamine saccharate, amphet…
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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: 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: 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 · 2023-09-27FDA 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 · 2023-09-07FDA 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 · 2023-08-24FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Golden State Medical Supply, Inc.)
FDA approved a supplemental ANDA from Golden State Medical Supply, Inc. to manufacture a generic combination of dextroamphetamine saccharate…
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FDA approval · 2023-07-12FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved the supplemental application for methylphenidate hydrochloride from Actavis Pharma, Inc., resulting in an approved supplemental…
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FDA approval · 2023-06-28FDA Approved: SUNOSI — Supplemental Application (Axsome Therapeutics, Inc.)
The FDA approved a supplemental application for Sunosi (solriamfetol) from Axsome Therapeutics, Inc., pertaining to updates to the drug's la…
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FDA approval · 2023-06-23FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
FDA approval of a supplemental application for a methylphenidate hydrochloride product from Lupin Pharmaceuticals, Inc.
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FDA approval · 2023-06-22FDA Approved: AMPHETAMINE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva's original application for generic Amphetamine, enabling marketing of amphetamine as a stimulant for ADHD and narcolepsy.