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Multitrace -4 Pediatric

MULTITRACE - 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP)

Approved
Approval ID

5ee6a685-3c35-467b-8d4d-79efdd0bfa8e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 25, 2019

Manufacturers
FDA

American Regent, Inc.

DUNS: 002033710

Products 1

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

Trace Elements 4

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0517-9203
Product Classification
G
Generic Name
Trace Elements 4
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 25, 2019
FDA Product Classification

INGREDIENTS (7)

SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
CUPRIC SULFATEActive
Quantity: 0.4 mg in 1 mL
Code: LRX7AJ16DT
Classification: ACTIM
MANGANESE SULFATEActive
Quantity: 77 ug in 1 mL
Code: W00LYS4T26
Classification: ACTIM
CHROMIC CHLORIDEActive
Quantity: 5.12 ug in 1 mL
Code: KB1PCR9DMW
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ZINC SULFATE HEPTAHYDRATEActive
Quantity: 4.39 mg in 1 mL
Code: N57JI2K7WP
Classification: ACTIM

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Multitrace -4 Pediatric - FDA Drug Approval Details