Ventricular Fibrillation

• FDA approval · 2010-08-31
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for amiodarone hydrochloride from Zydus Lifesciences Limited, authorizing the continued marketing of…

• FDA approval · 2010-02-04
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for amiodarone hydrochloride from Sun Pharmaceutical Industries, approving the supplemental filing f…

• FDA approval · 2010-02-04
  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 · 2009-12-01
  FDA Approved: PACERONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for PACERONE (amiodarone hydrochloride) by Upsher-Smith Laboratories, LLC, indicating a labeling or …

• FDA approval · 2009-11-20
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for amiodarone hydrochloride from Gland Pharma Limited.

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• FDA approval · 2009-07-10
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for amiodarone hydrochloride by Hikma Pharmaceuticals USA Inc., granting continued/updated approval …

• FDA approval · 2009-06-02
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2009-06-02
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for amiodarone hydrochloride from Sun Pharmaceutical Industries, Inc., granting additional regulator…

• FDA approval · 2009-01-15
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for amiodarone hydrochloride from Gland Pharma Limited, approving this generic product for marketing…

• FDA approval · 2008-12-24
  FDA Approved: NEXTERONE — Original Application (Baxter Healthcare Company)

  FDA approved NEXTERONE (amiodarone hydrochloride) injection under an original NDA for Baxter Healthcare Company. It is indicated for the tre…

• FDA approval · 2008-12-05
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for amiodarone hydrochloride from Sun Pharmaceutical Industries, Inc., formally updating the approva…

• FDA approval · 2008-11-06
  FDA Approved: AMIODARONE HYDROCHLORIDE — Original Application (Advagen Pharma Limited)

  FDA approved Amiodarone hydrochloride from Advagen Pharma Limited under an original application as a generic product. This indicates authori…

• FDA approval · 2008-09-16
  FDA Approved: AMIODARONE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved AMIODARONE HYDROCHLORIDE from Zydus Lifesciences Limited under an original generic application.

• FDA approval · 2008-03-24
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for amiodarone hydrochloride (generic antiarrhythmic) filed by Mylan Institutional LLC.

• FDA approval · 2008-02-25
  FDA Approved: AMIODARONE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc. amiodarone hydrochloride generic (ANDA 077234), providing a generic option for the treatment of …

• FDA approval · 2007-11-16
  FDA Approved: PACERONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for PACERONE (amiodarone hydrochloride) from Upsher-Smith Laboratories, LLC. The action modifies/exp…

• FDA approval · 2007-10-22
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for amiodarone hydrochloride (ANDA 075761) to support its manufacture by Fresenius Kabi USA, LLC.

• FDA approval · 2007-10-15
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for amiodarone hydrochloride submitted by Mylan Institutional LLC.

• FDA approval · 2007-04-12
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Labratories Inc.)

  FDA approved a supplemental application for amiodarone hydrochloride from Dr. Reddy's Laboratories Inc.

• FDA approval · 2007-04-11
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for amiodarone hydrochloride (generic) submitted by Chartwell RX, LLC.

• FDA approval · 2007-03-07
  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 Inc., enabling the generic product's …