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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
September 9, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Adenosine(3 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Akorn

Akorn

117696832

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
17478-953
Application Number
ANDA078076
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
October 26, 2017
AdenosineActive
Code: K72T3FS567Class: ACTIBQuantity: 3 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
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