Ventricular Tachycardia

• FDA approval · 2019-01-04
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Vitruvias Therapeutics)

  FDA approved Propafenone hydrochloride as an Abbreviated New Drug Application (ANDA) for a generic antiarrhythmic, with Vitruvias Therapeuti…

• FDA approval · 2017-11-03
  FDA Approved: FLECAINIDE ACETATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approves the original application for flecainide acetate by Rising Pharma Holdings, Inc., providing a generic antiarrhythmic product. In…

• 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 · 2017-09-08
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Propafenone hydrochloride generic product under an Original Application (ANDA).

• 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 …

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• 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 · 2016-05-29
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for Propafenone hydrochloride from Strides Pharma Science Limited.

• FDA approval · 2016-05-11
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for propafenone hydrochloride (generic) manufactured by Aurobindo Pharma Limited.

• 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 · 2015-08-25
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Sotalol hydrochloride from Aurobindo Pharma Limited. The approval confirms the generic product's…

• 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 · 2015-08-13
  FDA Approved: PROPAFENONE HCL — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Propafenone hydrochloride (Propafenone HCl) from Actavis Pharma, Inc.

• 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 · 2015-04-28
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for sotalol hydrochloride by Oxford Pharmaceuticals, LLC. Sotalol is used to treat certain heart…

• 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 · 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 · 2015-02-17
  FDA Approved: FLECAINIDE ACETATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for flecainide acetate from Hikma Pharmaceuticals USA Inc., expanding or authorizing changes to this…

• 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 · 2014-10-22
  FDA Approved: SOTYLIZE — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approved SOTYLIZE (sotalol hydrochloride) through an Original NDA from Azurity Pharmaceuticals for antiarrhythmic use.

• 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 · 2013-05-31
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for amiodarone hydrochloride from Sun Pharmaceutical Industries, Inc., approving a change under …

• 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.