Cardiac Arrhythmia

• FDA approval · 2014-08-27
  FDA Approved: METOPROLOL TARTRATE — Original Application (Almaject, Inc.)

  FDA approved Almaject, Inc.'s metoprolol tartrate as an original Abbreviated New Drug Application (ANDA), establishing a generic version of …

• FDA approval · 2013-05-28
  FDA Approved: METOPROLOL TARTRATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' metoprolol tartrate as an original generic product (ANDA 202871).

• 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.

• FDA approval · 2013-02-27
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for metoprolol tartrate from Hospira, Inc., indicating an updated regulatory action on the generic p…

• FDA approval · 2011-12-12
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for NEXTERONE (amiodarone hydrochloride) from Baxter Healthcare Company.

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• FDA approval · 2011-11-28
  FDA Approved: ATENOLOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for generic atenolol from Rising Pharma Holdings, Inc. under the ANDA.

• 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 · 2009-07-10
  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 · 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 · 2008-08-29
  FDA Approved: ATENOLOL — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Atenolol from Zydus Lifesciences Limited under the ANDA.

• FDA approval · 2008-04-29
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for TENORMIN (atenolol) submitted by Almatica Pharma LLC.

• 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 · 2007-11-07
  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 · 2007-10-15
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

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

• FDA approval · 2007-08-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma's generic propranolol hydrochloride product in an Original ANDA submission.

• 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 · 2007-01-03
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INDERAL LA (propranolol hydrochloride) submitted by ANI Pharmaceuticals, Inc. This action au…