Venous Thromboembolism

• FDA approval · 2022-02-15
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for Heparin Sodium submitted by Sandoz Inc., indicating an additional regulatory action on this gene…

• FDA approval · 2022-01-12
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for HEPARIN SODIUM from Sagent Pharmaceuticals, authorizing changes under an approved supplemental f…

• FDA approval · 2022-01-12
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for Heparin Sodium from Sagent Pharmaceuticals, confirming regulatory status and updates related to …

• FDA approval · 2020-12-29
  FDA Approved: HEPARIN SODIUM — Original Application (BE Pharmaceuticals Inc.)

  FDA approved the original ANDA for Heparin Sodium from BE Pharmaceuticals Inc., providing a generic version of heparin for anticoagulation.

• FDA approval · 2020-12-29
  FDA Approved: HEPARIN SODIUM — Original Application (BE Pharmaceuticals Inc.)

  The FDA approved BE Pharmaceuticals Inc.'s original application for Heparin Sodium (a generic anticoagulant). It is used to prevent and trea…

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• FDA approval · 2020-07-15
  FDA Approved: HEPARIN SODIUM — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' generic heparin sodium (Original Application) as an injectable anticoagulant. It covers the same indi…

• FDA approval · 2020-06-18
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ENOXAPARIN SODIUM by Sandoz Inc, signaling an approved change to the product's status under the …

• FDA approval · 2020-04-21
  FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)

  FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) submitted by Daiichi Sankyo Inc., likely updating labeling and/or in…

• FDA approval · 2020-04-02
  FDA Approved: HEPARIN SODIUM — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' original application for a generic heparin sodium product.

• FDA approval · 2019-11-20
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for Heparin Sodium from Gland Pharma Limited (ANDA205323). This action confirms continued availabili…

• FDA approval · 2019-10-31
  FDA Approved: WARFARIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Warfarin Sodium (Warfarin) from Amneal Pharmaceuticals LLC.

• 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 · 2019-08-23
  FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XARELTO (rivaroxaban) filed by Janssen Pharmaceuticals, resulting in labeling changes to the pro…

• FDA approval · 2019-05-28
  FDA Approved: HEPARIN SODIUM — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals Inc.'s Heparin Sodium as an Original Application (ANDA 211007), making a generic injectable anticoagul…

• FDA approval · 2018-12-20
  FDA Approved: HEPARIN SODIUM AND DEXTROSE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Hospira's Heparin Sodium and Dextrose (heparin sodium) product, authorizing changes under the ND…

• FDA approval · 2018-12-14
  FDA Approved: HEPARIN SODIUM — Original Application (NorthStar RxLLC)

  The FDA approved NorthStar RxLLC's original application for generic heparin sodium (ANDA211005).

• FDA approval · 2017-11-30
  FDA Approved: HEPARIN SODIUM — Original Application (Mylan Institutional LLC)

  FDA approved an Original Application for HEPARIN SODIUM (generic) from Mylan Institutional LLC, authorizing marketing of this anticoagulant.…

• FDA approval · 2016-04-25
  FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)

  The FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) submitted by Daiichi Sankyo to modify the label, reflecting upda…

• FDA approval · 2016-02-18
  FDA Approved: FONDAPARINUX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for fondaparinux sodium from Dr. Reddy's Laboratories Limited, enabling a new generic version of the…

• FDA approval · 2015-11-13
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Heparin Sodium submitted by Fresenius Kabi USA, LLC (NDA 017651). The approval updates labeling …

• FDA approval · 2015-10-26
  FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)

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

• FDA approval · 2015-08-24
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2015-08-18
  FDA Approved: HEPARIN SODIUM IN SODIUM CHLORIDE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved Baxter's Supplemental Application for Heparin Sodium in Sodium Chloride (Heparin Sodium), approving changes to an already-appro…

• FDA approval · 2015-01-15
  FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) submitted by Boehringer Ingelheim Pharmaceuticals In…