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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
April 20, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Adenosine(3 mg in 1 mL)

Products2

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
67457-855
Application Number
ANDA078686
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
April 20, 2022
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
AdenosineActive
Code: K72T3FS567Class: ACTIBQuantity: 3 mg in 1 mL
waterInactive
Code: 059QF0KO0RClass: IACT

adenosine

Product Details

NDC Product Code
67457-854
Application Number
ANDA078686
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
April 20, 2022
AdenosineActive
Code: K72T3FS567Class: ACTIBQuantity: 3 mg in 1 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
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