Narcolepsy

• FDA approval · 2008-01-29
  FDA 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…

• FDA approval · 2007-08-31
  FDA 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.

• FDA approval · 2007-08-31
  FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Dextroamphetamine sulfate from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2007-08-17
  FDA 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…

• FDA approval · 2007-06-15
  FDA 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 · 2007-05-22
  FDA 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…

• FDA approval · 2007-05-04
  FDA 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.

• FDA approval · 2007-05-01
  FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) from Amneal Pharmaceuticals LLC.

• FDA approval · 2007-04-25
  FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2007-03-23
  FDA 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 …

• FDA approval · 2006-11-13
  FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for sodium oxybate from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2006-08-10
  FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)

  The FDA approved a supplemental application for METHYLIN (methylphenidate hydrochloride) from Shionogi, resulting in labeling updates.

• FDA approval · 2006-08-10
  FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2006-08-08
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for methylphenidate from Sandoz Inc, updating an already approved product.

• FDA approval · 2006-08-08
  FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Ritalin (methylphenidate hydrochloride) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2006-08-07
  FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)

  FDA approved a supplemental application for Modafinil submitted by CIMA Labs Inc., resulting in an approved change to its labeling.

• FDA approval · 2006-07-26
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for a product containing dextroamphetamine saccharate, amphetamine aspartat…

• FDA approval · 2006-06-30
  FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for sodium oxybate from Hikma Pharmaceuticals USA Inc., signifying an approved update to the pro…

• FDA approval · 2006-06-16
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

  FDA granted a supplemental approval to Prasco Laboratories for a mixed amphetamine salts product containing dextroamphetamine and amphetamin…