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FDA Approval

Drax Exametazime

CompanyJubilant DraxImage Inc., dba Jubilant Radiopharma (DUNS: 243604761)

Effective Date

November 8, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Technetium Tc-99m exametazime(0.5 mg in 1 1)

Manufacturing Establishments (2)

Jubilant HollisterStier General Partnership

Labeler

Jubilant DraxImage Inc., dba Jubilant Radiopharma

DUNS Number

246762764

Jubilant DraxImage Inc., dba Jubilant Radiopharma

Labeler

Jubilant DraxImage Inc., dba Jubilant Radiopharma

DUNS Number

243604761

Products (1)

Drax Exametazime

NDC Product Code

65174-200

Application Number

NDA208870

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

August 28, 2017

Ingredients

NITROGENInactive

Code: N762921K75Class: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

STANNOUS CHLORIDEInactive

Code: 1BQV3749L5Class: IACT

Technetium Tc-99m exametazimeActive

Code: 3B744AG22NClass: ACTIRQuantity: 0.5 mg in 1 1

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