Leukotrap - CP2D Solution
Leukotrap RC PL System
Approved
Approval ID
98a1caaf-aaf0-47bf-8bdc-1eae486444f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2020
Manufacturers
FDA
Haemonetics Corporation
DUNS: 057827420
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Additive Solution - 3
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53157-124
Application NumberBN820915
Product Classification
M
Marketing Category
C73594
G
Generic Name
Additive Solution - 3
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 2, 2020
FDA Product Classification
INGREDIENTS (2)
DEXTROSEActive
Quantity: 1.21 g in 110 mL
Code: IY9XDZ35W2
Classification: ACTIB
ADENINEActive
Quantity: 0.033 g in 110 mL
Code: JAC85A2161
Classification: ACTIB
Anticoagulant Citrate Phosphate Double Dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53157-123
Application NumberBN820915
Product Classification
M
Marketing Category
C73594
G
Generic Name
Anticoagulant Citrate Phosphate Double Dextrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 2, 2020
FDA Product Classification
INGREDIENTS (1)
DEXTROSEActive
Quantity: 3.57 g in 70 mL
Code: IY9XDZ35W2
Classification: ACTIB