Atrial Fibrillation

• FDA label_change · 2025-07-02
  FDA Approved: WARFARIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Warfarin Sodium by Teva Pharmaceuticals USA, Inc., resulting in changes to the product labeling.…

• FDA label_change · 2025-04-16
  FDA Approved: CARDIZEM CD — Supplemental Application (Bausch Health US LLC)

  FDA approves a supplemental application for Cardizem CD (diltiazem hydrochloride) by Bausch Health US LLC.

• FDA label_change · 2024-08-13
  FDA Approved: MATZIM LA — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for MATZIM LA (diltiazem hydrochloride) from Actavis Pharma, Inc. to update labeling for this long-a…

• FDA label_change · 2018-09-20
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Covis Pharma US, Inc. The action updates the product labeling…

• FDA label_change · 2018-08-24
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  FDA approves a supplemental application for LANOXIN (digoxin) filed by Covis Pharma US, Inc., resulting in changes to the product labeling.

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• FDA label_change · 2016-11-18
  FDA Approved: CARDIZEM LA — Supplemental Application (Bausch Health US LLC)

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

• FDA label_change · 2016-11-02
  FDA Approved: DIGOXIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for digoxin from Sandoz Inc, resulting in a label change for the generic heart medication.

• FDA label_change · 2016-10-31
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for NEXTERONE (amiodarone hydrochloride) to update the product labeling, as filed by Baxter Healthca…

• FDA label_change · 2016-06-29
  FDA Approved: CARDIZEM CD — Supplemental Application (Bausch Health US LLC)

  FDA has approved a supplemental application for Cardizem CD (diltiazem hydrochloride) filed by Bausch Health US LLC under NDA 020062.

• FDA label_change · 2016-04-08
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (EXELA PHARMA SCIENCES, LLC)

  FDA approved a supplemental application for verapamil hydrochloride, resulting in changes to its labeling.

• FDA label_change · 2015-09-25
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (ALTATHERA Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Sotalol Hydrochloride submitted by ALTATHERA Pharmaceuticals, LLC, to modify the product lab…

• FDA label_change · 2015-07-28
  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 label_change · 2015-03-23
  FDA Approved: CARDIZEM LA — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental labeling application for Cardizem LA (diltiazem hydrochloride extended-release tablets) from Bausch Health US LL…

• FDA label_change · 2014-09-29
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

  The FDA approved a supplemental application for NEXTERONE (amiodarone hydrochloride) from Baxter Healthcare Company, resulting in changes to…

• FDA label_change · 2013-05-21
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental label change for Lanoxin (digoxin) submitted by Advanz Pharma (US) Corp.

• EMA label_change · 2012-05-25
  European Medicines Agency updates patient and prescriber information for Pradaxa

  EMA updates patient and prescriber information for Pradaxa to reflect new safety and usage details.

• FDA label_change · 2011-12-19
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Multaq (dronedarone) submitted by Sanofi-Aventis U.S. LLC, resulting in labeling updates for…

• FDA label_change · 2010-02-05
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for LANOXIN (digoxin) from Advanz Pharma (US) Corp., resulting in labeling changes for the produ…

• FDA label_change · 2007-10-18
  FDA Approved: TIKOSYN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

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