Deep Vein Thrombosis

• 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 · 2011-07-11
  FDA Approved: FONDAPARINUX SODIUM — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved the generic fondaparinux sodium product from Dr. Reddy's Laboratories Limited under ANDA 091316. This approval provides a gener…

• FDA approval · 2011-07-01
  FDA Approved: XARELTO — Original Application (Janssen Pharmaceuticals, Inc.)

  The FDA documents the approval of the original application for Xarelto (rivaroxaban) from Janssen Pharmaceuticals.

• FDA approval · 2010-10-19
  FDA Approved: PRADAXA — Original Application (Boehringer Ingelheim Pharmaceuticals Inc.)

  The FDA approved Pradaxa (dabigatran etexilate mesylate) under an original NDA from Boehringer Ingelheim Pharmaceuticals Inc.

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• FDA approval · 2010-07-23
  FDA Approved: ENOXAPARIN SODIUM — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's Original Application for Enoxaparin Sodium, a generic injectable anticoagulant. The approval authorizes marketing …

• 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 · 2010-03-26
  FDA Approved: ARIXTRA — Supplemental Application (Mylan Institutional LLC)

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

• FDA approval · 2009-12-23
  FDA Approved: FRAGMIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Fragmin (dalteparin sodium) submitted by Pfizer Laboratories Div Pfizer Inc. The action indicate…

• 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 · 2009-07-23
  FDA Approved: HEPARIN SODIUM AND DEXTROSE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Heparin Sodium and Dextrose (Heparin Sodium) from Hospira, Inc. The approval updates the product…

• 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 · 2007-01-12
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for ENOXAPARIN SODIUM submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2006-10-04
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Civica, Inc.)

  The FDA approved Civica, Inc.'s supplemental application for Heparin Sodium. This action updates the product labeling as part of the NDA 017…

• 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.