Deep Vein Thrombosis

• FDA approval · 2022-07-28
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for enoxaparin sodium from Gland Pharma Limited.

• FDA approval · 2022-06-14
  FDA Approved: ENOXAPARIN SODIUM — Original Application (BluePoint Laboratories)

  The FDA approved BluePoint Laboratories' original ANDA for enoxaparin sodium, a low molecular weight heparin, expanding availability of its …

• 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, 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.

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• 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…

• FDA approval · 2020-08-25
  FDA Approved: ARIXTRA — Supplemental Application (Mylan Institutional LLC)

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

• 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 · 2020-05-06
  FDA Approved: DABIGATRAN ETEXILATE — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved the original application for a generic dabigatran etexilate (ANDA 207961) from XLCare Pharmaceuticals, confirming the generic’s…

• 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 · 2020-03-19
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Italfarmaco SpA)

  FDA approved a supplemental application for ENOXAPARIN SODIUM submitted by Italfarmaco SpA.

• FDA approval · 2020-03-11
  FDA Approved: DABIGATRAN ETEXILATE — Original Application (Major Pharmaceuticals)

  FDA approved the original application for dabigatran etexilate from Major Pharmaceuticals, approving a generic version of the anticoagulant …

• 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 · 2019-03-14
  FDA Approved: ENOXAPARIN SODIUM — Original Application (Amphastar Pharmaceuticals, Inc.)

  FDA approved Amphastar Pharmaceuticals' generic enoxaparin sodium injection (ANDA 208600). This marks approval of a generic version of enoxa…

• 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 · 2018-12-11
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a Supplemental Application for enoxaparin sodium from Sanofi-Aventis U.S. LLC to update the product labeling.

• FDA approval · 2018-11-14
  FDA Approved: FONDAPARINUX SODIUM — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approves the Original Application for fondaparinux sodium from Zydus Pharmaceuticals (USA) Inc., a generic anticoagulant.

• FDA approval · 2017-12-26
  FDA Approved: FONDAPARINUX SODIUM — Original Application (Eugia US LLC)

  FDA approved a generic version of fondaparinux sodium (Eugia US LLC) through an Original ANDA, enabling use of this anticoagulant for preven…