MedPath

Leukotrap - CP2D

Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D)

Approved
Approval ID

e154f8b7-89a0-dfbb-e053-2995a90a300a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 13, 2022

Manufacturers
FDA

Haemonetics Corporation

DUNS: 057827420

Products 1

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

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53157-455
Application NumberBN820915
Product Classification
M
Marketing Category
C73594
G
Generic Name
ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2022
FDA Product Classification

INGREDIENTS (5)

SODIUM CITRATEInactive
Quantity: 2.63 g in 100 mL
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.327 g in 100 mL
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 0.222 g in 100 mL
Code: 593YOG76RN
Classification: IACT
DEXTROSE, UNSPECIFIED FORMActive
Quantity: 4.64 g in 100 mL
Code: IY9XDZ35W2
Classification: ACTIB

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Leukotrap - CP2D - FDA Drug Approval Details