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FDA NDA · NDA020855

MESNEX

mesna

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA020855
TYPE
NDA
ORIGINAL APPROVAL
2002-03-21
LATEST ACTION
2018-12-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MESNEX · ReferencePrescription
MESNA 400MG · TABLET · ORAL

Approval history

2018-12-17Labeling · Supplement 3 · standard — Label ↗AP
2014-03-17Labeling · Supplement 2 · standard — Letter ↗AP
2012-12-28Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2002-03-21Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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