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FDA ANDA · ANDA090212

ADENOSINE

Sponsor: MYLAN ASI

APPLICATION
ANDA090212
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-28
LATEST ACTION
2016-04-08
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ADENOSINEPrescription
ADENOSINE 90MG/30ML (3MG/ML) · SOLUTION · INTRAVENOUS
ADENOSINEPrescription
ADENOSINE 60MG/20ML (3MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2016-04-08Labeling · Supplement 5 · standardAP
2014-09-24Manufacturing (CMC) · Supplement 2AP
2014-03-28OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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