Hemorrhagic Disease of the Newborn

• FDA approval · 2026-03-13
  FDA Approved: PHYTONADIONE — Original Application (Orbicular Pharmaceutical Technologies Private Limited)

  The FDA approved Orbicular Pharmaceutical Technologies Private Limited's Original Application for PHYTONADIONE, a generic vitamin K1 (phyton…

• FDA approval · 2025-11-04
  FDA Approved: PHYTONADIONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's original-application generic PHYTONADIONE (phytonadione) for vitamin K deficiency-related conditions, including preven…

• FDA approval · 2025-09-08
  FDA Approved: PHYTONADIONE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' original ANDA for PHYTONADIONE (phytonadione), a generic vitamin K1 product.

• FDA approval · 2025-04-17
  FDA Approved: PHYTONADIONE — Original Application (Caplin Steriles Limited)

  FDA approved Caplin Steriles Limited's original ANDA for PHYTONADIONE (phytonadione, vitamin K1), a generic vitamin K1 product. The approval…

• FDA approval · 2025-01-03
  FDA Approved: PHYTONADIONE — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s original application for PHYTONADIONE (phytonadione), a generic vitamin K1 product.

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• FDA approval · 2024-12-10
  FDA Approved: PHYTONADIONE — Original Application (Gland Pharma Limited)

  FDA approved an Original Application for phytonadione (vitamin K1) from Gland Pharma Limited, adding a generic supply of the product.

• FDA approval · 2023-10-12
  FDA Approved: PHYTONADIONE — Original Application (Agnitio Inc.)

  FDA approved Agnitio Inc.'s phytonadione (vitamin K1) via an original ANDA, enabling its generic use for preventing and treating vitamin K d…

• FDA approval · 2023-07-28
  FDA Approved: PHYTONADIONE — Original Application (Cipla USA., Inc.)

  The FDA approved Cipla USA, Inc.'s phytonadione (vitamin K1) under an original application, establishing a generic option for vitamin K supp…

• FDA approval · 2022-04-22
  FDA Approved: PHYTONADIONE — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s original application for phytonadione (vitamin K1), a generic product. The approval authorizes marketing of th…

• FDA approval · 2019-05-22
  FDA Approved: PHYTONADIONE PHYTONADIONE — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approved PHYTONADIONE (phytomenadione) from Dr. Reddy's Laboratories Inc under an Original Application as a generic vitamin K product. T…