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FDA Approval

Adenosine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Akorn
DUNS: 117693100
Effective Date
January 29, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Adenosine(3 mg in 1 mL)

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
17478-542
Application Number
ANDA078076
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
January 29, 2024
AdenosineActive
Code: K72T3FS567Class: ACTIBQuantity: 3 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
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