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Leukotrap - AS-3

Additive Solution Formula 3

Approved
Approval ID

e15674bf-142b-653c-e053-2995a90a726a

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.

AS-3

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53157-460
Application NumberBN820915
Product Classification
M
Marketing Category
C73594
G
Generic Name
AS-3
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2022
FDA Product Classification

INGREDIENTS (7)

SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE, UNSPECIFIED FORMActive
Quantity: 1 g in 100 mL
Code: IY9XDZ35W2
Classification: ACTIB
ADENINEActive
Quantity: 0.03 g in 100 mL
Code: JAC85A2161
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

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Leukotrap - AS-3 - FDA Drug Approval Details