Atrial Fibrillation

• 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 · 2008-07-17
  FDA Approved: DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Diltiazem Hydrochloride Extended-Release from Endo USA, Inc., resulting in an approved update to…

• FDA approval · 2008-03-28
  FDA Approved: JANTOVEN — Supplemental Application (Upsher-Smith Laboratories, LLC)

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

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• 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 · 2008-03-20
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2008-03-20
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC, signifying approval of a gener…

• 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 · 2007-11-07
  FDA Approved: FLECAINIDE ACETATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for flecainide acetate from Hikma Pharmaceuticals USA Inc., approving changes to the approved generi…

• FDA approval · 2007-10-30
  FDA Approved: DIGOXIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Digoxin under an original ANDA, allowing generic Digoxin from Hikma Pharmaceuticals USA Inc. to be marketed.

• 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 · 2007-07-11
  FDA Approved: WARFARIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Warfarin Sodium from Teva Pharmaceuticals USA, Inc. for the generic product under the ANDA.

• FDA approval · 2007-06-21
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride (generic) from Hikma Pharmaceuticals USA Inc., indicating an approval …

• FDA approval · 2007-06-14
  FDA Approved: DIGOXIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Digoxin from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2007-05-11
  FDA Approved: CARTIA XT — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for CARTIA XT (diltiazem hydrochloride) from Actavis Pharma, Inc.

• FDA approval · 2007-04-27
  FDA Approved: CARDIZEM LA — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for Cardizem LA (diltiazem hydrochloride extended-release) from Bausch Health US LLC.

• FDA approval · 2007-04-19
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for verapamil hydrochloride from Actavis Pharma, Inc., granting approval of a supplemental indicatio…

• 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 · 2007-04-12
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Verapamil Hydrochloride from Actavis Pharma, Inc., confirming regulatory approval of an upda…

• FDA approval · 2007-04-12
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Verapamil Hydrochloride from Actavis Pharma, Inc., updating the approval status for this generic…

• 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 …