Ventricular Fibrillation

• 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 · 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.

• 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 · 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).

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• 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 · 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 · 2019-10-29
  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…

• FDA approval · 2017-10-25
  FDA Approved: AMIODARONE HYDROCHLORIDE — Original Application (AuroMedics Pharma LLC)

  The FDA approved the original ANDA for amiodarone hydrochloride, a generic antiarrhythmic, from AuroMedics Pharma LLC.

• FDA approval · 2015-10-05
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for amiodarone hydrochloride submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2015-08-13
  FDA Approved: PACERONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for PACERONE (amiodarone hydrochloride) from Upsher-Smith Laboratories.

• FDA approval · 2015-07-02
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for amiodarone hydrochloride by Advagen Pharma Limited. This action confirms regulatory clearance fo…

• FDA approval · 2015-05-19
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Amiodarone Hydrochloride (generic) from Chartwell RX, LLC, confirming the generic product's stat…

• FDA approval · 2015-03-13
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

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

• FDA approval · 2014-12-21
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for amiodarone hydrochloride submitted by Sun Pharmaceutical Industries, signifying a regulatory…

• FDA approval · 2014-12-21
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for amiodarone hydrochloride from Sun Pharmaceutical Industries, Inc., indicating regulatory approva…

• FDA approval · 2013-05-31
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for amiodarone hydrochloride submitted by Chartwell RX, LLC. This marks an approval of a supplement …

• FDA approval · 2013-05-21
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  The FDA approved a supplemental application for amiodarone hydrochloride from Gland Pharma Limited, enabling its generic use.

• FDA approval · 2013-04-29
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for NEXTERONE (amiodarone hydrochloride) submitted by Baxter Healthcare Company.

• FDA approval · 2011-12-12
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

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

• FDA approval · 2011-08-17
  FDA Approved: BETAPACE — Supplemental Application (Legacy Pharma USA, Inc.)

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