Atrial Flutter

• 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 · 2015-04-06
  FDA Approved: DIGOXIN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Digoxin, submitted by Amneal Pharmaceuticals of New York LLC.

• 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 · 2015-02-23
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Digoxin submitted by Hikma Pharmaceuticals USA Inc.

• 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…

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• FDA approval · 2015-01-26
  FDA Approved: BREVIBLOC — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Brevibloc (esmolol hydrochloride) submitted by Baxter Healthcare Corporation.

• 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 · 2014-09-04
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for sotalol hydrochloride (generic). This action confirms regulatory clearance related to the g…

• FDA approval · 2014-07-03
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for DIGOXIN from Hikma Pharmaceuticals USA Inc., resulting in changes to the approved product labeli…

• FDA approval · 2014-06-09
  FDA Approved: CORVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for CORVERT (ibutilide fumarate) filed by Pharmacia & Upjohn Company LLC, signaling a regulatory upd…

• FDA approval · 2014-03-31
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Multaq (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2014-03-19
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental NDA for MULTAQ (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2014-01-30
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for MULTAQ (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2013-12-06
  FDA Approved: TIKOSYN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Tikosyn (dofetilide) from Pfizer Laboratories Div Pfizer Inc.

• 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 · 2013-05-21
  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 · 2013-05-16
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Covis Pharma US, Inc.

• FDA approval · 2013-03-27
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA posted a supplemental approval application for MULTAQ (dronedarone) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2012-12-07
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s generic diltiazem hydrochloride (ANDA 202463). The product is indicated for the management of hypertensi…

• FDA approval · 2012-11-26
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for verapamil hydrochloride from Actavis Pharma, Inc. for an already authorized product.

• FDA approval · 2012-09-07
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Multaq (dronedarone) filed by Sanofi-Aventis U.S. LLC. The approval updates the drug's labeling …

• FDA approval · 2012-08-24
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental abbreviated new drug application for diltiazem hydrochloride from Sun Pharmaceutical, a generic calcium channel …

• FDA approval · 2012-08-13
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Advanz Pharma (US) Corp.