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FDA Approval

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)

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

FDA Approval Summary

Company
Terumo Corporation
DUNS: 690543319
Effective Date
December 7, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Citric acid(2.99 g in 1000 mL)
Glucose(31.9 g in 1000 mL)
Adenine(0.275 g in 1000 mL)
Sodium phosphate, dibasic(2.22 g in 1000 mL)
Gadofosveset trisodium(26.3 g in 1000 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Terumo Corp. - Fujinomiya Factory

Terumo Corporation

695214015

Products1

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

TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)

Product Details

NDC Product Code
53877-001
Application Number
BN820528
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
December 7, 2018
Citric acidActive
Code: XF417D3PSLClass: ACTIBQuantity: 2.99 g in 1000 mL
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 31.9 g in 1000 mL
AdenineActive
Code: JAC85A2161Class: ACTIBQuantity: 0.275 g in 1000 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium phosphate, dibasicActive
Code: 593YOG76RNClass: ACTIBQuantity: 2.22 g in 1000 mL
Gadofosveset trisodiumActive
Code: B22547B95KClass: ACTIMQuantity: 26.3 g in 1000 mL
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