Narcolepsy

• FDA approval · 2013-09-19
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Cranbury Pharmaceuticals, LLC)

  The FDA approved a supplemental application for methylphenidate hydrochloride submitted by Cranbury Pharmaceuticals, LLC. The approval confi…

• FDA approval · 2013-07-31
  FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (Aurolife Pharma, LLC)

  FDA approved Aurolife Pharma, LLC's dextroamphetamine sulfate as an original-application generic, authorizing a generic stimulant for attent…

• FDA approval · 2013-07-09
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lannett Company, Inc.)

  FDA approved the original ANDA for a generic methylphenidate hydrochloride product by Lannett Company, Inc.

• FDA approval · 2013-06-14
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental NDA for a four-salt amphetamine product (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextro…

• FDA approval · 2013-06-07
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc.

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• FDA approval · 2013-06-07
  FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) from Novartis Pharmaceuticals Corporation, signaling an …

• FDA approval · 2013-05-29
  FDA Approved: DEXTROAMPHETAMINE — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approves Cranbury Pharmaceuticals' original ANDA for dextroamphetamine, a generic stimulant indicated for attention-deficit/hyperactivit…

• FDA approval · 2013-05-06
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc under NDA 021284, marking an additional approval for the…

• FDA approval · 2013-05-06
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for methylphenidate hydrochloride CD from Lannett Company, Inc., authorizing its marketing as a …

• FDA approval · 2013-03-08
  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 generic combination of amphetamine salts (dextroamphetamine saccharat…

• FDA approval · 2012-12-19
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for methylphenidate hydrochloride from SpecGx LLC, indicating regulatory approval for an existing ge…

• FDA approval · 2012-12-19
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for methylphenidate hydrochloride from SpecGx LLC. The approval confirms the generic product's appro…

• FDA approval · 2012-12-17
  FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc., resulting in updated labeling.

• FDA approval · 2012-10-18
  FDA Approved: MODAFINIL — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's Original Application for Modafinil as a generic version of the wakefulness-promoting drug. Th…

• FDA approval · 2012-09-27
  FDA Approved: MODAFINIL — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved a generic form of modafinil from Rising Pharma Holdings, Inc.

• FDA approval · 2012-09-26
  FDA Approved: MODAFINIL — Original Application (Bionpharma Inc.)

  FDA approved Bionpharma's original application for a generic Modafinil product, authorizing marketing in the United States for the treatment…

• FDA approval · 2012-07-13
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE (LA) — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved the original application for methylphenidate hydrochloride (LA) from Teva Pharmaceuticals USA, Inc. as a long-acting generic st…

• FDA approval · 2012-06-22
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma's generic combination of four amphetamine salt components under an Original Application (ANDA) for ADHD and narc…

• FDA approval · 2012-06-01
  FDA Approved: ARMODAFINIL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved an original application for armodafinil from Mylan Pharmaceuticals Inc., enabling a generic version of the wakefulness-promotin…

• FDA approval · 2012-03-27
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2012-02-07
  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 four-salt amphetamine combination (dextroamphetamine saccharate, amph…

• FDA approval · 2011-12-01
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE (LA) — Original Application (Dr. Reddy's Laboratories Inc)

  FDA approved the original application for a generic methylphenidate hydrochloride extended-release product (LA) from Dr. Reddy's Laboratorie…

• FDA approval · 2011-10-25
  FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (Wilshire Pharmaceuticals, Inc.)

  The FDA approved Wilshire Pharmaceuticals' generic dextroamphetamine sulfate under an original ANDA. The product is intended for the same in…

• FDA approval · 2010-12-10
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  The FDA approved a supplemental application for methylphenidate hydrochloride submitted by SpecGx LLC.

• FDA approval · 2010-12-09
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for methylphenidate by Sandoz Inc, resulting in an updated label for the product.