Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Jubilant HollisterStier General Partnership
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Jubilant DraxImage Inc., dba Jubilant Radiopharma
246762764
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Jubilant DraxImage Inc., dba Jubilant Radiopharma
243604761
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DRAXIMAGE DTPA
Product Details
NDC Product Code
65174-288Application Number
NDA018511Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUS, RESPIRATORY (INHALATION)Effective Date
June 13, 2023Pentetic acidActive
Code: 7A314HQM0IClass: ACTIBQuantity: 20 mg in 1 1
Stannous ChlorideInactive
Code: 1BQV3749L5Class: IACTQuantity: 0.25 mg in 1 1
Aminobenzoic AcidInactive
Code: TL2TJE8QTXClass: IACTQuantity: 5 mg in 1 1
Calcium ChlorideInactive
Code: M4I0D6VV5MClass: IACTQuantity: 3.73 mg in 1 1