Atrial Fibrillation

• FDA approval · 2020-04-28
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's diltiazem hydrochloride as an original generic application (ANDA) for the established indications of diltia…

• FDA approval · 2020-03-27
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for verapamil hydrochloride from Nivagen Pharmaceuticals, Inc., updating regulatory status for this …

• 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 · 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 · 2020-01-29
  FDA Approved: DOFETILIDE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves the original Abbreviated New Drug Application for dofetilide from Novadoz Pharmaceuticals LLC, enabling a generic version of th…

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• FDA approval · 2019-12-11
  FDA Approved: DOFETILIDE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for dofetilide submitted by NorthStar RxLLC (ANDA210466), indicating changes to the generic prod…

• 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 · 2019-10-31
  FDA Approved: WARFARIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Warfarin Sodium (Warfarin) from Amneal Pharmaceuticals LLC.

• FDA approval · 2019-10-31
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Propafenone Hydrochloride from Glenmark Pharmaceuticals Inc., USA.

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

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

• FDA approval · 2019-10-04
  FDA Approved: DIGOXIN — Original Application (VistaPharm, LLC)

  The FDA approved VistaPharm’s original (ANDA) application for digoxin, granting marketing approval for a generic digoxin product.

• FDA approval · 2019-10-01
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals Inc)

  The FDA approved a supplemental application for Verapamil Hydrochloride by Teva Pharmaceuticals Inc., updating the drug’s labeling and appro…

• FDA approval · 2019-09-26
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for Verapamil Hydrochloride from Glenmark Pharmaceuticals, updating an already approved generic …

• FDA approval · 2019-09-26
  FDA Approved: WARFARIN SODIUM — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Warfarin Sodium by Exelan Pharmaceuticals. This action updates the regulatory status of this…

• FDA approval · 2019-09-25
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for verapamil hydrochloride (generic) from Nivagen Pharmaceuticals, Inc., authorizing the sale o…

• FDA approval · 2019-09-20
  FDA Approved: JANTOVEN — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for JANTOVEN (warfarin sodium) submitted by Upsher-Smith Laboratories, LLC.

• FDA approval · 2019-08-23
  FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XARELTO (rivaroxaban) filed by Janssen Pharmaceuticals, resulting in labeling changes to the pro…

• 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 · 2019-08-14
  FDA Approved: ESMOLOL HYDROCHLORIDE — Original Application (Gland Pharma Limited)

  The FDA approved the original abbreviated application for esmolol hydrochloride from Gland Pharma Limited, confirming a generic esmolol hydr…

• FDA approval · 2019-08-08
  FDA Approved: TIKOSYN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for TIKOSYN (dofetilide) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2019-06-14
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved Ingenus Pharmaceuticals' generic diltiazem hydrochloride via an original ANDA submission.