Pseudobulbar Affect

• FDA approval · 2024-08-28
  FDA Approved: DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for a generic combination product of dextromethorphan hydrobromide and quinidi…

• FDA approval · 2019-06-11
  FDA Approved: NUEDEXTA — Supplemental Application (Otsuka America Pharmaceutical, Inc)

  FDA approved a supplemental application for NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) from Otsuka America Pharmaceutica…

• FDA approval · 2019-01-31
  FDA Approved: NUEDEXTA — Supplemental Application (Otsuka America Pharmaceutical, Inc)

  FDA approved a supplemental application for NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) from Otsuka America Pharmaceutica…

• FDA approval · 2017-04-21
  FDA Approved: NUEDEXTA — Supplemental Application (Otsuka America Pharmaceutical, Inc)

  FDA approved a supplemental application for NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) from Otsuka America Pharmaceutica…

• FDA approval · 2015-08-14
  FDA Approved: NUEDEXTA — Supplemental Application (Otsuka America Pharmaceutical, Inc)

  FDA approved a supplemental application for NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) submitted by Otsuka America Pharm…

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• FDA approval · 2015-01-20
  FDA Approved: NUEDEXTA — Supplemental Application (Otsuka America Pharmaceutical, Inc)

  The FDA approved a supplemental application for NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) filed by Otsuka America Pharm…

• EMA approval · 2013-04-26
  European Medicines Agency recommends approval of first treatment for pseudobulbar affect

  The EMA recommends approval of the first treatment specifically targeting pseudobulbar affect, signaling a new therapeutic option for this c…

• FDA approval · 2012-11-30
  FDA Approved: NUEDEXTA — Supplemental Application (Otsuka America Pharmaceutical, Inc)

  The FDA approved a supplemental application for NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) submitted by Otsuka America P…

• FDA approval · 2010-10-29
  FDA Approved: NUEDEXTA — Original Application (Otsuka America Pharmaceutical, Inc)

  FDA approved NUEDEXTA from the Original Application (NDA) for the fixed-dose combination of dextromethorphan hydrobromide and quinidine sulf…