Pulmonary Embolism

• FDA approval · 2024-06-14
  FDA Approved: DABIGATRAN ETEXILATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' Original Application for dabigatan etexilate as a generic version of Pradaxa, an oral anticoagulant in…

• FDA approval · 2024-05-22
  FDA Approved: DABIGATRAN — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original ANDA (ANDA213879) for DABIGATRAN (Dabigatan etexilate), a generic anticoagulant. The approval enables Novadoz Phar…

• FDA approval · 2023-12-15
  FDA Approved: DABIGATRAN ETEXILATE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original application for dabigatran etexilate as a generic anticoagulant. The generic will have the same indicat…

• FDA approval · 2023-10-18
  FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)

  FDA approves a supplemental application for SAVAYSA (edoxaban tosylate) from Daiichi Sankyo, resulting in an update to the drug’s labeling.

• FDA approval · 2023-09-29
  FDA Approved: TECHNEGAS — Original Application (Cyclomedica Australia Pty Limited)

  The FDA approved Technegas as an original application for a kit to prepare Tc-99m-labeled carbon inhalation aerosol used for lung ventilatio…

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• FDA approval · 2023-08-25
  FDA Approved: PULMOTECH MAA — Supplemental Application (Curium US LLC)

  FDA approved a supplemental application for PULMOTECH MAA, a radiopharmaceutical kit used to prepare Technetium-99m macroaggregated albumin …

• FDA approval · 2022-11-15
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Amphastar Pharmaceuticals, Inc.)

  FDA approves Amphastar Pharmaceuticals' supplemental application for enoxaparin sodium.

• FDA approval · 2022-08-23
  FDA Approved: WARFARIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Warfarin sodium submitted by Amneal Pharmaceuticals LLC.

• 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, 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…

• 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 · 2020-03-20
  FDA Approved: PULMOTECH MAA — Original Application (Curium US LLC)

  FDA approves Pulmotech MAA, a kit for preparing Technetium-99m-labeled aggregated albumin used for pulmonary perfusion imaging.

• 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.