Pulmonary Embolism

• 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 · 2014-05-29
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Heparin Sodium (Hospira, Inc.), updating the approved generic product under the ANDA program.

• 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 · 2014-03-06
  FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XARELTO (rivaroxaban) submitted by Janssen Pharmaceuticals, Inc. This action approves changes re…

• FDA approval · 2013-11-15
  FDA Approved: ARIXTRA — Supplemental Application (Mylan Institutional LLC)

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

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• FDA approval · 2013-10-22
  FDA Approved: FRAGMIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA page indicates Pfizer's supplemental application for FRAGMIN (dalteparin sodium) under NDA 020287 is under consideration for a supplemen…

• FDA approval · 2013-09-12
  FDA Approved: ARIXTRA — Supplemental Application (Mylan Institutional LLC)

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

• FDA approval · 2013-06-05
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for enoxaparin sodium (Lovenox) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2013-05-20
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Hospira's heparin sodium, indicating a modification to the product's approval (likely labeling o…

• FDA approval · 2013-03-04
  FDA Approved: DRAXIMAGE MAA — Supplemental Application (Jubilant DraxImage Inc)

  FDA approved a supplemental application for the DRAXIMAGE MAA kit used to prepare Tc-99m albumin aggregated for lung perfusion imaging, incl…

• 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.

• 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 · 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.

• 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 · 2009-08-31
  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.