APPLICATION
ANDA075739
TYPE
ANDA
ORIGINAL APPROVAL
2004-01-09
LATEST ACTION
2024-07-17
ROUTE
INTRAVENOUS, Injection
DOSAGE FORM
Injectable, INJECTABLE
MARKETING STATUS
Prescription
Products
MESNAPrescription
MESNA 1G/10ML · Injectable · Injection
MESNAPrescription
MESNA 100MG/ML · INJECTABLE · INTRAVENOUS
Approval history
2024-07-17Labeling · Supplement 10 · standardAP
2024-07-17Labeling · Supplement 9 · standardAP
2024-07-17Labeling · Supplement 7 · standardAP
2004-01-09OriginalAP
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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