Atrial Flutter

• 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 · 2018-08-24
  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.

• 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 · 2016-06-29
  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.

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• 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 · 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.

• 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 · 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.