Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
HF Acquisition Co LLC, DBA HealthFirst
045657305
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
045657305
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ADENOSINE
Product Details
NDC Product Code
51662-1631Application Number
ANDA078686Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
April 28, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
AdenosineActive
Code: K72T3FS567Class: ACTIBQuantity: 3 mg in 1 mL