Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2010-11-12FDA 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 amphetamine product (dextroamphetamine saccharate, amphetam…
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FDA approval · 2010-10-21FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)
FDA approved a supplemental application for modafinil submitted by CIMA Labs, resulting in changes to the drug's labeling.
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FDA approval · 2010-10-18FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for methylphenidate hydrochloride CD from Lannett Company, Inc. under NDA 021259, authorizing co…
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FDA approval · 2010-09-23FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for a Sandoz generic combination of four amphetamine salt components (dextroamphetamine and amphetam…
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FDA approval · 2010-04-27FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc.
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FDA approval · 2009-08-11FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application from Teva Pharmaceuticals USA, Inc. for a combination of four amphetamine salts: dextroamphetamine s…
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FDA approval · 2009-05-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)
FDA approved Epic Pharma LLC's supplemental application for a generic product containing four amphetamine salts: dextroamphetamine saccharat…
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FDA approval · 2009-04-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental NDA for Methylphenidate Hydrochloride CD (generic from Lannett) to authorize its continued marketing as a methyl…
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FDA approval · 2009-03-26FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)
FDA approved a supplemental application for NUVIGIL (armodafinil) submitted by Cephalon, LLC. This approval covers changes to the product la…
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FDA approval · 2008-11-12FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for Prasco Laboratories to market a generic combination of amphetamine salts (dextroamphetamine sacc…
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FDA approval · 2008-08-11FDA 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 combination of four amphetamine salts: dextroamphetamine saccharate, amphetamine …
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FDA approval · 2008-05-23FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) from Amneal Pharmaceuticals LLC.
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FDA approval · 2008-02-06FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for dextroamphetamine sulfate, a generic stimulant indicated for atte…
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FDA approval · 2008-01-29FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (Prasco Laboratories)
FDA approves a generic form of dextroamphetamine sulfate from Prasco Laboratories under an Original Application, for ADHD and narcolepsy ind…
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FDA approval · 2007-08-31FDA Approved: DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Dextroamphetamine Sulfate Extended-Release, a generic product manufactured by SpecGx LLC.
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FDA approval · 2007-08-31FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Dextroamphetamine sulfate from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2007-08-17FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)
FDA approved a supplemental application for Modafinil submitted by CIMA Labs Inc. to update the product's labeling under the supplemental fi…
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FDA approval · 2007-06-15FDA Approved: NUVIGIL — Original Application (Cephalon, LLC)
FDA approved NUVIGIL (armodafinil) in its original application from Cephalon, LLC. It is approved for excessive daytime sleepiness associate…
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FDA approval · 2007-05-22FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application from Prasco Laboratories for a combination of four amphetamine salt–forms (dextroamphetamine sacchar…
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FDA approval · 2007-05-04FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride CD from Lannett Company, Inc., under NDA 021259.
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FDA approval · 2007-05-01FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) from Amneal Pharmaceuticals LLC.
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FDA approval · 2007-04-25FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2007-03-23FDA Approved: DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for Dextroamphetamine Sulfate Extended-Release submitted by SpecGx LLC. This action pertains to …
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FDA approval · 2006-11-13FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate from Hikma Pharmaceuticals USA Inc.
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FDA approval · 2006-08-10FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)
The FDA approved a supplemental application for METHYLIN (methylphenidate hydrochloride) from Shionogi, resulting in labeling updates.