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FDA NDA · NDA217569

VASOPRESSIN IN 0.9% SODIUM CHLORIDE

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA217569
TYPE
NDA
ORIGINAL APPROVAL
2023-09-29
LATEST ACTION
2025-02-21
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VASOPRESSIN IN SODIUM CHLORIDE 0.9% · ReferencePrescription
VASOPRESSIN 20UNITS/100ML (0.2UNITS/ML) · SOLUTION · INTRAVENOUS
VASOPRESSIN IN SODIUM CHLORIDE 0.9% · ReferencePrescription
VASOPRESSIN 40UNITS/100ML (0.4UNITS/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-02-21Labeling · Supplement 3 · standard — Letter ↗AP
2024-02-05Manufacturing (CMC) · Supplement 1 — Label ↗AP
2023-09-29Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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