Cardiac Arrhythmia

• 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 · 2024-09-09
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Verapamil Hydrochloride (Hospira, Inc.), confirming it as an approved generic drug under an ANDA…

• FDA approval · 2024-07-11
  FDA Approved: NADOLOL — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for Nadolol from Alembic Pharmaceuticals Limited, expanding access to this generic beta-blocker.

• FDA approval · 2023-11-22
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate from Aurobindo Pharma Limited. The action confirms approval of changes to an…

• FDA approval · 2023-11-07
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Inderal LA (propranolol hydrochloride) by ANI Pharmaceuticals, Inc. The action confirms regulato…

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• 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 · 2022-02-10
  FDA Approved: QUINIDINE SULFATE — Supplemental Application (EPIC PHARMA, LLC)

  FDA approved a supplemental application for Quinidine Sulfate tablets from Epic Pharma, LLC.

• FDA approval · 2021-02-16
  FDA Approved: ISOPROTERENOL HYDROCHLORIDE — Original Application (Armas Pharmaceuticals Inc.)

  FDA approved Armas Pharmaceuticals' Isoproterenol Hydrochloride Original Application (ANDA210845) to manufacture a generic product. Isoprote…

• 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 · 2020-05-04
  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 · 2020-03-25
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Caplin Steriles Limited)

  FDA approves Caplin Steriles Limited's Verapamil Hydrochloride under an Original Application (ANDA). This confirms the availability of a gen…

• 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 · 2019-11-13
  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 · 2019-10-30
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for propafenone hydrochloride, a generic antiarrhythmic drug. This approval s…

• 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 · 2017-08-02
  FDA Approved: ISOPROTERENOL HYDROCHLORIDE — Original Application (Nexus Pharmaceuticals LLC)

  FDA approved Nexus Pharmaceuticals LLC's original-application submission for isoproterenol hydrochloride, making this generic beta-adrenergi…

• FDA approval · 2017-03-22
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for Nexterone (amiodarone hydrochloride) submitted by Baxter Healthcare Company associated with NDA …

• FDA approval · 2016-11-22
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

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

• FDA approval · 2016-04-08
  FDA Approved: ADENOSINE — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for Adenosine submitted by Mylan Institutional 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 · 2015-09-08
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Metoprolol Tartrate from Aurobindo Pharma Limited, a generic beta-blocker used in cardiovascular…

• FDA approval · 2015-08-13
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for metoprolol tartrate from Fresenius Kabi USA, LLC.

• FDA approval · 2015-03-02
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (AiPing Pharmaceutical, Inc.)

  FDA approved AiPing Pharmaceutical, Inc.'s supplemental application for sotalol hydrochloride, confirming approval of a generic product's su…

• FDA approval · 2014-12-09
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for propranolol hydrochloride by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2014-12-09
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental ANDA for propranolol hydrochloride by Amneal Pharmaceuticals NY LLC, authorizing a new generic propranolol hydro…