Valvular Heart Disease

• FDA approval · 2024-03-01
  FDA Approved: DEFINITY — Supplemental Application (Lantheus Medical Imaging, Inc.)

  FDA approved a supplemental application for DEFINITY (perflutren) from Lantheus Medical Imaging, Inc., resulting in updated labeling and/or …

• FDA approval · 2019-09-26
  FDA Approved: WARFARIN SODIUM — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Warfarin Sodium by Exelan Pharmaceuticals. This action updates the regulatory status of this…

• FDA approval · 2019-09-20
  FDA Approved: JANTOVEN — Supplemental Application (Upsher-Smith Laboratories, LLC)

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

• FDA approval · 2012-03-27
  FDA Approved: JANTOVEN — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Jantoven (warfarin sodium) submitted by Upsher-Smith Laboratories.

• 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.

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