Atrial Fibrillation

• 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 · 2021-03-22
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approves Glenmark's diltiazem hydrochloride as an original ANDA; the product is a generic calcium channel blocker indicated for hyperten…

• FDA approval · 2021-03-02
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Verapamil Hydrochloride by Mylan Pharmaceuticals, signaling approval of an updated or additional…

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

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

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2020-11-30
  FDA Approved: DOFETILIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application from Aurobindo Pharma Limited to manufacture and market dofetilide as a generic drug.

• FDA approval · 2020-11-16
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a supplemental application for Multaq (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2020-11-12
  FDA Approved: DIGOXIN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Digoxin submitted by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2020-10-15
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Sagent Pharmaceuticals)

  The FDA approved the original application for Verapamil hydrochloride from Sagent Pharmaceuticals, establishing a generic version of this ca…

• FDA approval · 2020-10-15
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original application for Verapamil hydrochloride from Zydus Pharmaceuticals USA Inc., confirming the generic formulation of…

• FDA approval · 2020-10-07
  FDA Approved: DIGOXIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for digoxin filed by Sun Pharmaceutical Industries, Inc. to update the drug's labeling.

• FDA approval · 2020-10-07
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for digoxin submitted by Hikma Pharmaceuticals USA Inc., authorizing changes to the product as r…

• 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 · 2020-07-06
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Eugia US LLC)

  FDA approves Verapamil hydrochloride as an original application generic; the product is used to treat hypertension, angina, and certain arrh…

• FDA approval · 2020-06-25
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Propafenone hydrochloride as an Original Application (generic) for Upsher-Smith Laboratories, 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 · 2020-06-19
  FDA Approved: DOFETILIDE — Original Application (Accord Healthcare, Inc.)

  FDA has approved Accord Healthcare's original application for the generic antiarrhythmic dofetilide to treat atrial fibrillation and atrial …

• FDA approval · 2020-05-14
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Somerset Therapeutics, LLC)

  FDA approved a supplemental application for verapamil hydrochloride, a generic version, filed by Somerset Therapeutics, 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 · 2020-04-29
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for diltiazem hydrochloride (generic) under ANDA074185.