Atrial 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 · 2010-08-12
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for verapamil hydrochloride from Mylan Pharmaceuticals Inc., granting/confirming approval for a …

• FDA approval · 2010-07-30
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for amiodarone hydrochloride from Gland Pharma Limited (ANDA 077161).

• FDA approval · 2010-07-06
  FDA Approved: DIGOXIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Digoxin from Sun Pharmaceutical Industries, expanding/ updating the approved Digoxin product…

• FDA approval · 2010-05-18
  FDA Approved: DIGOXIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Digoxin (Sandoz Inc), indicating an approved modification to this generic product's labeling/app…

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• FDA approval · 2010-04-26
  FDA Approved: DIGOXIN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approves Amneal Pharmaceuticals of New York LLC's supplemental application for Digoxin (DIGOXIN), a generic product.

• FDA approval · 2010-03-15
  FDA Approved: MATZIM LA — Original Application (Actavis Pharma, Inc.)

  FDA approved MATZIM LA, a diltiazem hydrochloride extended-release tablet, under Actavis Pharma's original ANDA.

• FDA approval · 2010-02-05
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Lanoxin (digoxin) from Covis Pharma US, Inc., resulting in updates to the product labeling under…

• 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 · 2009-12-16
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Verapamil Hydrochloride filed by Wilshire Pharmaceuticals, Inc.

• FDA approval · 2009-12-03
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for verapamil hydrochloride by Mylan Pharmaceuticals Inc., enabling the generic version to be market…

• 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.

• FDA approval · 2009-09-17
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's verapamil hydrochloride as an original generic application, adding a new generic calcium channel blocker to the mark…

• FDA approval · 2009-07-20
  FDA Approved: DIGOXIN — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved the Amneal Pharmaceuticals of New York LLC original application for digoxin (generic digoxin). This approves a generic version …

• 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 · 2009-07-09
  FDA Approved: FLECAINIDE ACETATE — Original Application (Chartwell RX, LLC)

  FDA approved flecainide acetate under an Original Application (ANDA) for Chartwell RX, LLC, enabling a generic version of this antiarrhythmi…

• FDA approval · 2009-07-02
  FDA Approved: SOTALOL HYDROCHLORIDE — Original Application (ALTATHERA Pharmaceuticals, LLC)

  FDA approved ALTATHERA Pharmaceuticals' original application for sotalol hydrochloride, a beta-blocker used to manage certain arrhythmias.

• FDA approval · 2009-07-01
  FDA Approved: MULTAQ — Original Application (Sanofi-Aventis U.S. LLC)

  FDA approved MULTAQ (dronedarone) from Sanofi-Aventis U.S. LLC as the original application. It is indicated to reduce the risk of cardiovasc…

• 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 · 2008-12-17
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s original application for diltiazem hydrochloride (generic). This approval makes a generic vers…

• FDA approval · 2008-12-05
  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.