Ventricular Tachycardia

• FDA approval · 2025-07-23
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (ALTATHERA Pharmaceuticals, LLC)

  FDA approved a supplemental application for sotalol hydrochloride from ALTATHERA Pharmaceuticals, indicating an update to its labeling and/o…

• FDA approval · 2025-02-21
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

  The FDA approved a supplemental application for NEXTERONE (amiodarone hydrochloride) from Baxter Healthcare Company.

• FDA approval · 2025-02-04
  FDA Approved: PROCAINAMIDE HYDROCHLORIDE — Original Application (Caplin Steriles Limited)

  FDA approved Caplin Steriles Limited's original ANDA for Procainamide hydrochloride, a generic antiarrhythmic drug.

• FDA approval · 2024-10-17
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for Propafenone Hydrochloride filed by Strides Pharma Science Limited, adding a approved generic…

• FDA approval · 2024-09-11
  FDA Approved: AMIODARONE HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals)

  FDA approved the original application for Amiodarone hydrochloride (Slate Run Pharmaceuticals) as a generic antiarrhythmic agent.

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• 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 · 2024-04-30
  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 · 2023-09-11
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approves Apotex Corp.'s supplemental application for sotalol hydrochloride, enabling a generic version of the antiarrhythmic for clinica…

• FDA approval · 2023-02-21
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic Propafenone hydrochloride product from Aurobindo Pharma Limited under an Original Application. This marks market entr…

• FDA approval · 2022-10-25
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for sotalol hydrochloride by Teva Pharmaceuticals USA, Inc., indicating regulatory approval of a…

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

  FDA approved a supplemental application for sotalol hydrochloride by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2020-09-16
  FDA Approved: FLECAINIDE ACETATE — Original Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved flecainide acetate from Unichem Pharmaceuticals (USA), Inc. as an original ANDA (210683) for the treatment of documented tachya…

• FDA approval · 2020-07-21
  FDA Approved: AMIODARONE HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved the Original Application for Amiodarone Hydrochloride from Unichem Pharmaceuticals (USA), Inc., confirming regulatory appro…

• FDA approval · 2020-07-15
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for amiodarone hydrochloride (Chartwell RX, LLC).

• FDA approval · 2020-06-23
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  The FDA approved a supplemental application for amiodarone hydrochloride from Gland Pharma Limited.

• FDA approval · 2020-06-23
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for amiodarone hydrochloride from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2020-06-23
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for amiodarone hydrochloride from Sun Pharmaceutical Industries, Inc. The approval relates to change…

• FDA approval · 2020-05-04
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for amiodarone hydrochloride from Fresenius Kabi USA, LLC.

• 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 · 2019-11-21
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Labratories Inc.)

  The FDA approved a supplemental application for Amiodarone hydrochloride from Dr. Reddy's Laboratories, enabling the generic product's marke…

• FDA approval · 2019-11-14
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for propafenone hydrochloride from Rising Pharma Holdings, providing a generic version of the an…

• FDA approval · 2019-11-13
  FDA Approved: PROCAINAMIDE HYDROCHLORIDE — Supplemental Application (International Medication Systems, Limited)

  FDA approved a supplemental application for Procainamide hydrochloride from International Medication Systems, Limited.

• FDA approval · 2019-11-13
  FDA Approved: PROPAFENONE HCL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Propafenone HCl, marking the approval of a generic Propafenone hydrochloride product from Actavi…

• FDA approval · 2019-10-29
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Amiodarone Hydrochloride from Zydus Lifesciences Limited.

• FDA approval · 2019-08-15
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for amiodarone hydrochloride, granting approval for a generi…