Ventricular Arrhythmia

• FDA approval · 2024-04-30
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for sotalol hydrochloride from Aurobindo Pharma Limited, authorizing the generic product's approval.

• FDA approval · 2023-09-12
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for sotalol hydrochloride from Oxford Pharmaceuticals, LLC under an ANDA.

• FDA approval · 2023-06-15
  FDA Approved: BETAPACE — Supplemental Application (Legacy Pharma USA, Inc.)

  The FDA approved a supplemental application for BETAPACE (sotalol hydrochloride) from Legacy Pharma USA, Inc.

• FDA approval · 2023-02-28
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for Sotalol hydrochloride from Oxford Pharmaceuticals, LLC.

• FDA approval · 2022-08-26
  FDA Approved: MEXILETINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original Abbreviated New Drug Application for mexiletine hydrochloride by Rising Pharma Holdings, making a generic antiarrh…

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• FDA approval · 2021-06-03
  FDA Approved: BETAPACE — Supplemental Application (Legacy Pharma USA, Inc.)

  FDA approved a supplemental application for Betapace (sotalol hydrochloride) filed by Legacy Pharma USA, Inc.

• FDA approval · 2021-01-25
  FDA Approved: MEXILETINE HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Mexiletine hydrochloride as a generic drug from Ingenus Pharmaceuticals under an Original Application (ANDA214352).

• FDA approval · 2020-03-06
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (ALTATHERA Pharmaceuticals, LLC)

  FDA approves a supplemental application for sotalol hydrochloride from ALTATHERA Pharmaceuticals, LLC.

• FDA approval · 2015-08-25
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Sotalol hydrochloride from Aurobindo Pharma Limited. The approval confirms the generic product's…

• FDA approval · 2015-04-29
  FDA Approved: MEXILETINE HYDROCHLORIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Mexiletine Hydrochloride from ANI Pharmaceuticals, Inc., indicating regulatory approval of c…

• FDA approval · 2010-10-18
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Strides Pharma Science Limited)

  FDA approved Propafenone hydrochloride from Strides Pharma Science Limited under an Original Application, making a generic antiarrhythmic av…

• FDA approval · 2007-02-07
  FDA Approved: SOTALOL HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  The FDA approved the original application for sotalol hydrochloride (generic) from Aurobindo Pharma Limited, authorizing its marketing as a …