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FDA ANDA · ANDA206992

MESNA

mesna injection

Sponsor: GLAND

APPLICATION
ANDA206992
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-18
LATEST ACTION
2019-09-06
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MESNAPrescription
MESNA 100MG/ML · INJECTABLE · INTRAVENOUS

Approval history

2019-09-06Labeling · Supplement 3 · standardAP
2019-09-06Labeling · Supplement 1 · standardAP
2017-12-18UNKNOWN · Original · standardAP
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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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