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FDA NDA · NDA022231

TERLIVAZ

terlipressin

Sponsor: MALLINCKRODT IRELAND

APPLICATION
NDA022231
TYPE
NDA
ORIGINAL APPROVAL
2022-09-14
LATEST ACTION
2026-06-10
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

TERLIVAZ · ReferencePrescription
TERLIPRESSIN ACETATE EQ 0.85MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2026-06-10Labeling · Supplement 4 · standard — Letter ↗AP
2023-01-09Labeling · Supplement 1 · standard — Label ↗AP
2022-09-14Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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