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FDA NDA · NDA019884

MESNA

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA019884
TYPE
NDA
ORIGINAL APPROVAL
1988-12-30
LATEST ACTION
2018-12-17
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MESNEX · ReferencePrescription
MESNA 100MG/ML · INJECTABLE · INTRAVENOUS

Approval history

2018-12-17Labeling · Supplement 16 · standard — Label ↗AP
2016-02-26Manufacturing (CMC) · Supplement 15 · priorityAP
2014-03-17Labeling · Supplement 13 · standard — Label ↗AP
2003-01-30Labeling · Supplement 7 · priority — Letter ↗AP
2003-01-30Labeling · Supplement 8 · standard — Letter ↗AP
2000-07-26Manufacturing (CMC) · Supplement 6 · priorityAP
1996-05-23Manufacturing (CMC) · Supplement 4 · priorityAP
1995-09-25Labeling · Supplement 5 · standardAP
1994-11-16Manufacturing (CMC) · Supplement 2 · priorityAP
1993-04-22Manufacturing (CMC) · Supplement 3 · priorityAP
1988-12-30Type 1 - New Molecular Entity · Original · priorityAP
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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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