Terlivaz

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 163837383

Effective Date

May 11, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Terlipressin(0.85 mg in 5 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

43825-200

Application Number

NDA022231

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

April 1, 2023

Ingredients

Code: 7Z5X49W53PClass: ACTIBQuantity: 0.85 mg in 5 mL