Venous Thromboembolism

• FDA approval · 2014-06-12
  FDA Approved: HEPARIN SODIUM — Original Application (Sandoz Inc.)

  FDA approved Sandoz Inc.'s original application for generic heparin sodium, an injectable anticoagulant used to prevent and treat thrombotic…

• FDA approval · 2014-03-19
  FDA Approved: FONDAPARINUX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental ANDA for Fondaparinux sodium from Dr. Reddy's Laboratories Limited, authorizing the generic product to be market…

• FDA approval · 2013-01-10
  FDA Approved: HEPARIN SODIUM IN SODIUM CHLORIDE — Supplemental Application (B. Braun Medical Inc.)

  FDA approves a supplemental application for HEPARIN SODIUM IN SODIUM CHLORIDE from B. Braun Medical Inc., expanding its labeling for anticoa…

• FDA approval · 2012-12-19
  FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)

  FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) from Boehringer Ingelheim Pharmaceuticals Inc., to modif…

• FDA approval · 2012-11-02
  FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XARELTO (rivaroxaban) filed by Janssen Pharmaceuticals, Inc.

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• 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 · 2011-12-23
  FDA Approved: HEPARIN SODIUM AND DEXTROSE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Heparin Sodium and Dextrose (Hospira, Inc.). The update concerns labeling/indications for this a…

• FDA approval · 2011-11-09
  FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)

  FDA approved Boehringer Ingelheim Pharmaceuticals' supplemental application for Pradaxa (dabigatran etexilate mesylate).

• FDA approval · 2010-06-30
  FDA Approved: HEPARIN SODIUM — Original Application (Sagent Pharmaceuticals)

  FDA approved the original application for heparin sodium from Sagent Pharmaceuticals.

• FDA approval · 2010-06-11
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Heparin Sodium from Fresenius Kabi USA, LLC.

• FDA approval · 2009-08-31
  FDA Approved: HEPARIN SODIUM — Original Application (Hospira, Inc.)

  FDA approved an original ANDA for heparin sodium, enabling its generic commercialization by Hospira, Inc.

• FDA approval · 2009-08-14
  FDA Approved: ARIXTRA — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for ARIXTRA (fondaparinux sodium) submitted by Mylan Institutional LLC.

• FDA approval · 2008-10-17
  FDA Approved: ARIXTRA — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for ARIXTRA (fondaparinux sodium) filed by Mylan Institutional LLC. The approval updates the exi…

• FDA approval · 2008-03-28
  FDA Approved: JANTOVEN — Supplemental Application (Upsher-Smith Laboratories, LLC)

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

• FDA approval · 2007-12-14
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Civica, Inc.)

  FDA approved Civica, Inc.'s supplemental application for HEPARIN SODIUM. This action approves a supplemental NDA related to the product (NDA…

• 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.

• FDA approval · 2006-07-05
  FDA Approved: WARFARIN SODIUM — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's Warfarin Sodium generic under an Original Application (ANDA) for this oral anticoagulant.

• FDA approval · 2006-05-05
  FDA Approved: JANTOVEN — Supplemental Application (Upsher-Smith Laboratories, LLC)

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