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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
Effective Date
December 4, 2018
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.

Fresenius Kabi Austria

Fresenius Kabi USA, LLC

300206604

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
63323-651
Application Number
ANDA205568
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
November 20, 2018
AdenosineActive
Code: K72T3FS567Class: ACTIBQuantity: 3 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
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