Original New Drug Application Approvals by US FDA (01 - 15 January 2021)

20 Jan 2021
Original New Drug Application Approvals by US FDA (01 - 15 January 2021)
New drug applications approved by US FDA as of 01 - 15 January 2021 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

NOREPINEPHRINE BITARTRATE; DEXTROSE
  • Active Ingredient(s): Norepinephrine bitartrate; Dextrose
  • Strength:16 MCG/ML; 32 MCG/ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Baxter Healthcare Corp.
  • Approval Date: 15 Jan 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for restoration of blood pressure in adult patients with acute hypotensive states.
  • Approved Label: 15 Jan 2021 (PDF)