Vitamin Deficiency

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

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

• EMA approval · 2024-12-16
  EMA Authorised: Vedrop (tocofersolan) — Recordati Rare Diseases

  The EMA has authorised Vedrop (tocofersolan) for the treatment of cholestasis-associated vitamin E deficiency under the marketing authorisat…

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• 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…

• FDA approval · 2018-12-07
  FDA Approved: ERGOCALCIFEROL CAPSULES, — Original Application (Epic Pharma LLC)

  FDA approved Ergocalciferol Capsules (ergocalciferol) from Epic Pharma LLC via an Original Abbreviated New Drug Application (ANDA 204276). T…

• FDA approval · 2017-10-02
  FDA Approved: ASCOR — Original Application (McGuff Pharmaceuticals, Inc.)

  FDA approved ASCOR (ascorbic acid) from McGuff Pharmaceuticals as an original NDA; the product is intended to treat and prevent vitamin C de…

• FDA approval · 2015-12-02
  FDA Approved: INFUVITE PEDIATRIC — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for INFUVITE PEDIATRIC, a pediatric multivitamin injection from Sandoz Inc, expanding its labeli…

• FDA approval · 2013-09-04
  FDA Approved: INFUVITE ADULT — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for INFUVITE ADULT, a multiple vitamins injection from Sandoz Inc, under NDA 021163.

• FDA approval · 2010-08-03
  FDA Approved: VITAMIN D — Original Application (Strides Pharma Science Limited)

  FDA approves Strides Pharma Science Limited's generic vitamin D product ergocalciferol under an Original Application (ANDA 090455).