Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Apotex Inc.
209429182
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Regadenoson
Product Details
NDC Product Code
60505-6116Application Number
ANDA207604Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
March 14, 2023RegadenosonActive
Code: 2XLN4Y044HClass: ACTIMQuantity: 0.08 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT