Narcolepsy

• FDA approval · 2015-01-29
  FDA 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 mixed amphetamine salt product containing dextroamphetamine and amphet…

• FDA approval · 2015-01-29
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental ANDA for a generic fixed-dose combination of dextroamphetamine and amphetamine salts (dextroamphetamine sacchara…

• FDA approval · 2015-01-15
  FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)

  The FDA approved a supplemental application for Modafinil submitted by CIMA Labs Inc., resulting in updated regulatory labeling for the prod…

• FDA approval · 2015-01-15
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's supplemental application for a generic product containing the four amphetamine salt components (mixed amph…

• FDA approval · 2014-11-05
  FDA Approved: MODAFINIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Modafinil submitted by Rising Pharma Holdings, Inc. The approval indicates the sponsor's supplem…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2014-11-03
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for a generic fixed-dose combination of dextroamphetamine and amphetamine salts manufactured by Epic…

• FDA approval · 2014-09-15
  FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)

  FDA approved a supplemental application for METHYLIN (methylphenidate hydrochloride) submitted by Shionogi Inc.

• FDA approval · 2014-09-12
  FDA Approved: EVEKEO — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EVEKEO (amphetamine sulfate) from Azurity Pharmaceuticals, Inc., resulting in an updated lab…

• FDA approval · 2014-07-24
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for a product containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine …

• FDA approval · 2014-06-10
  FDA 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 fixed-dose combination of amphetamine salts (dextroamphetamine saccharate, amphet…

• FDA approval · 2014-03-12
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a generic methylphenidate hydrochloride product from Amneal Pharmaceuticals of New York LLC under an Original Application, …

• FDA approval · 2014-02-13
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for a generic combination of amphetamine salts (dextroamphetamine saccharate, amphetamine a…

• FDA approval · 2014-02-03
  FDA Approved: MODAFINIL — Original Application (Apotex Corp.)

  The FDA approved the original application for generic modafinil by Apotex Corp., authorizing their modafinil product as a generic version.

• FDA approval · 2014-01-22
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental ANDA for a combination of amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate monohydrate, de…

• FDA approval · 2014-01-16
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' supplemental application for methylphenidate hydrochloride. The approval pertains to a labeling …

• FDA approval · 2013-12-31
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)

  The FDA approved a supplemental application for Epic Pharma's generic combination of amphetamine salts (dextroamphetamine saccharate, amphet…

• FDA approval · 2013-12-31
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for methylphenidate hydrochloride (generic) from Lannett Company, Inc., confirming regulatory approv…

• FDA approval · 2013-12-20
  FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for sodium oxybate from Hikma Pharmaceuticals USA, resulting in labeling updates for the product.

• FDA approval · 2013-12-13
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for a generic methylphenidate hydrochloride CD product by Lannett Company, expanding the availab…

• FDA approval · 2013-12-13
  FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2013-12-13
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental NDA for methylphenidate from Sandoz Inc.

• FDA approval · 2013-12-03
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a four-salt dextroamphetamine/amphetamine product manufactured by Prasco Laboratories.

• FDA approval · 2013-11-27
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's generic mixed amphetamine salts product (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetami…

• FDA approval · 2013-09-25
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for a generic fixed-combination amphetamine product containing dextroamphetamine saccharate, am…

• FDA approval · 2013-09-23
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lannett Company, Inc.)

  The FDA approved Lannett Company's original application for methylphenidate hydrochloride, enabling the marketing of a generic methylphenida…