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.
Institutt For Energiteknikk
Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc.
518771688
Cardinal Health 414, LLC
Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc.
079955366
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Xofigo
Product Details
NDC Product Code
50419-208Application Number
NDA203971Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
May 24, 2017SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Radium Ra 223 dichlorideActive
Code: RJ00KV3VTGClass: ACTIBQuantity: 30 uCi in 1 mL
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT