APPLICATION
ANDA075811
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-26
LATEST ACTION
2019-09-15
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MESNAPrescription
MESNA 100MG/ML · INJECTABLE · INTRAVENOUS
Approval history
2019-09-15Labeling · Supplement 14 · standardAP
2015-11-18Labeling · Supplement 12 · standardAP
2002-12-05Manufacturing (CMC) · Supplement 2AP
2002-05-13Manufacturing (CMC) · Supplement 1AP
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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