Ventricular Arrhythmias

• FDA approval · 2026-03-23
  FDA Approved: MEXILETINE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved an original ANDA for Mexiletine hydrochloride, a generic antiarrhythmic drug manufactured by Macleods Pharmaceuticals Limited.

• FDA approval · 2024-05-15
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for sotalol hydrochloride (generic). This action authorizes changes to the previously approved …

• FDA approval · 2024-01-12
  FDA Approved: SOTYLIZE — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for SOTYLIZE (sotalol hydrochloride) from Azurity Pharmaceuticals, Inc.

• FDA approval · 2023-08-29
  FDA Approved: MEXILETINE HYDROCHLORIDE — Supplemental Application (Senores Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for a generic Mexiletine hydrochloride product from Senores Pharmaceuticals, Inc.

• FDA approval · 2022-11-09
  FDA Approved: MEXILETINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved the original application for Mexiletine hydrochloride (generic) from Camber Pharmaceuticals.

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• FDA approval · 2022-09-08
  FDA Approved: FLECAINIDE ACETATE — Original Application (Epic Pharma, LLC)

  FDA approved the original application for flecainide acetate tablets from Epic Pharma, LLC under ANDA215599.

• FDA approval · 2022-05-25
  FDA Approved: MEXILETINE HYDROCHLORIDE — Original Application (Senores Pharmaceuticals, Inc.)

  FDA approved the original application for Mexiletine hydrochloride (generic) from Senores Pharmaceuticals, Inc., adding a generic option. Th…

• FDA approval · 2021-04-21
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approves Zydus Lifesciences Limited's original application for propafenone hydrochloride (generic). The approval covers the treatment of…

• FDA approval · 2021-02-04
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (AiPing Pharmaceutical, Inc.)

  FDA approved AiPing Pharmaceutical, Inc.'s supplemental application for Sotalol Hydrochloride.

• FDA approval · 2021-01-27
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Sotalol Hydrochloride from Apotex Corp., approving changes to this generic product.

• FDA approval · 2020-07-22
  FDA Approved: MEXILETINE HYDROCHLORIDE — Original Application (Chartwell RX, LLC)

  FDA approved an original abbreviated new drug application for mexiletine hydrochloride (generic) to Chartwell RX, LLC.

• FDA approval · 2018-11-02
  FDA Approved: SOTALOL HYDROCHLORIDE AF — Original Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved Sotalol Hydrochloride AF tablets from Unichem Pharmaceuticals (USA), Inc. as an original application generic product for treati…

• FDA approval · 2017-09-08
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Propafenone hydrochloride generic product under an Original Application (ANDA).

• FDA approval · 2016-10-21
  FDA Approved: SOTALOL — Original Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved an original ANDA for sotalol hydrochloride (Sotalol) from Unichem Pharmaceuticals (USA), Inc., enabling generic access to this …

• FDA approval · 2016-05-10
  FDA Approved: BETAPACE — Supplemental Application (Legacy Pharma USA, Inc.)

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

• FDA approval · 2015-12-21
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Inderal LA (propranolol hydrochloride) by ANI Pharmaceuticals, Inc., granting approval for chang…

• FDA approval · 2015-07-01
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for sotalol hydrochloride from Apotex Corp., indicating approval of a generic sotalol product.

• FDA approval · 2015-04-28
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for sotalol hydrochloride by Oxford Pharmaceuticals, LLC. Sotalol is used to treat certain heart…

• FDA approval · 2015-04-27
  FDA Approved: MEXILETINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for mexiletine hydrochloride (Teva) to update its labeling.

• FDA approval · 2014-09-04
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for sotalol hydrochloride (generic). This action confirms regulatory clearance related to the g…

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

  FDA approves a supplemental application for Propafenone hydrochloride from Strides Pharma Science Limited to market its generic product.

• FDA approval · 2010-07-30
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for amiodarone hydrochloride from Gland Pharma Limited (ANDA 077161).

• FDA approval · 2007-10-22
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for amiodarone hydrochloride (ANDA 075761) to support its manufacture by Fresenius Kabi USA, LLC.

• FDA approval · 2007-02-08
  FDA Approved: DISOPYRAMIDE PHOSPHATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for disopyramide phosphate from Teva Pharmaceuticals USA, Inc., indicating an approved update to…

• FDA approval · 2006-12-26
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for sotalol hydrochloride, a generic antiarrhythmic, under the AN…