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Technescan MAG3

Technescan MAG3™Kit for the Preparation of Technetium Tc 99m Mertiatide

Approved
Approval ID

0571c18b-1d5e-47bd-bddf-54d74ce1b442

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 13, 2022

Manufacturers
FDA

Curium US LLC

DUNS: 079875617

Products 1

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

Technescan Tc 99m Mertiatide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69945-096
Application NumberNDA019882
Product Classification
M
Marketing Category
C73594
G
Generic Name
Technescan Tc 99m Mertiatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 13, 2022
FDA Product Classification

INGREDIENTS (7)

BETIATIDEActive
Quantity: 1 mg in 1 1
Code: 9NV2SR34P8
Classification: ACTIB
STANNOUS CHLORIDE ANHYDROUSInactive
Quantity: 0.2 mg in 1 1
Code: R30H55TN67
Classification: IACT
LACTOSE MONOHYDRATEInactive
Quantity: 20 mg in 1 1
Code: EWQ57Q8I5X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
STANNOUS CHLORIDEInactive
Quantity: 0.05 mg in 1 1
Code: 1BQV3749L5
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM TARTRATEInactive
Quantity: 40 mg in 1 1
Code: QTO9JB4MDD
Classification: IACT

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Technescan MAG3 - FDA Drug Approval Details