Preeclampsia

• FDA approval · 2026-03-26
  FDA Approved: LABETALOL HYDROCHLORIDE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for labetalol hydrochloride submitted by NorthStar Rx LLC.

• FDA approval · 2025-06-06
  FDA Approved: LABETALOL HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd)

  FDA approves Advagen Pharma Ltd's supplemental application for labetalol hydrochloride (generic), updating the product's regulatory status.

• FDA approval · 2025-05-28
  FDA Approved: MAGNESIUM SULFATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original application for a generic Magnesium Sulfate Heptahydrate product. This approval introduces a g…

• FDA approval · 2023-02-15
  FDA Approved: MAGNESIUM SULFATE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' magnesium sulfate in water for injection under an Original Application, providing a generic option. Mag…

• FDA approval · 2020-11-09
  FDA Approved: LABETALOL HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved LABETALOL HYDROCHLORIDE (labetalol hydrochloride) from Hikma Pharmaceuticals USA Inc. under an Original Application. The dr…

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• FDA approval · 2019-04-16
  FDA Approved: MAGNESIUM SULFATE IN DEXTROSE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for Magnesium Sulfate in Dextrose (Magnesium Sulfate in Dextrose injection), updating the pr…

• FDA approval · 2016-03-02
  FDA Approved: MAGNESIUM SULFATE IN DEXTROSE — Original Application (WG Critical Care, LLC)

  FDA approved a new original application for Magnesium Sulfate in Dextrose injection from WG Critical Care, LLC (ANDA 207349).

• FDA approval · 2016-02-29
  FDA Approved: MAGNESIUM SULFATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Magnesium Sulfate Heptahydrate from Fresenius Kabi USA, LLC, updating the product's approval…

• FDA approval · 2015-07-14
  FDA Approved: MAGNESIUM SULFATE IN DEXTROSE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for MAGNESIUM SULFATE IN DEXTROSE from Hospira, Inc., effectively updating the NDA for this product.