Narcolepsy

• FDA label_change · 2024-03-12
  FDA Approved: AMPHETAMINE EXTENDED-RELEASE — Supplemental Application (Neos Therapeutics, LP)

  The FDA approved a supplemental application for AMPHETAMINE EXTENDED-RELEASE by Neos Therapeutics, LP.

• FDA label_change · 2023-10-13
  FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)

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

• FDA label_change · 2022-12-01
  FDA Approved: SUNOSI — Supplemental Application (Axsome Therapeutics, Inc.)

  FDA approves Axsome Therapeutics' supplemental application for Sunosi (solriamfetol), signaling an updated labeling for the product.

• FDA label_change · 2021-12-09
  FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Sodium Oxybate (Hikma Pharmaceuticals USA Inc.), resulting in changes to the product's labeling.

• FDA label_change · 2019-11-19
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc, resulting in labeling changes for the product.

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• FDA label_change · 2014-07-14
  FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) filed by Novartis Pharmaceuticals Corporation, resul…

• FDA label_change · 2014-04-11
  FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

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

• FDA label_change · 2014-03-29
  FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for dextroamphetamine sulfate from Teva Pharmaceuticals USA, Inc., resulting in updated labeling…

• FDA label_change · 2013-06-11
  FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) from Amneal Pharmaceuticals LLC, resulting in cha…

• FDA label_change · 2010-12-09
  FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) submitted by Novartis, resulting in updated labeling for…