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FDA Approval

Pall Sterile Cord Blood Collection Unit

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

FDA Approval Summary

Effective Date
December 20, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Glucose(0.893 g in 35 mL)
Sodium citrate(0.921 g in 35 mL)
VS-01(0.114 g in 35 mL)
Sodium phosphate, dibasic(0.0078 g in 35 mL)

Manufacturing Establishments1

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

Haemonetics Manufacturing Inc.

Global Life Sciences Solutions USA LLC

078598396

Products1

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

Pall Sterile Cord Blood Collection Unit

Product Details

NDC Product Code
79403-791
Application Number
BN800222
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
December 20, 2023
WATERInactive
Code: 059QF0KO0RClass: IACTQuantity: 35 g in 35 mL
PHOSPHORIC ACIDInactive
Code: E4GA8884NNClass: IACT
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 0.893 g in 35 mL
Code: 1Q73Q2JULRClass: ACTIBQuantity: 0.921 g in 35 mL
VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.114 g in 35 mL
Code: 593YOG76RNClass: ACTIBQuantity: 0.0078 g in 35 mL
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