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FDA NDA · NDA009166

HYDROXYSTILBAMIDINE ISETHIONATE

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA009166
TYPE
NDA
ORIGINAL APPROVAL
1953-12-22
LATEST ACTION
1987-03-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

HYDROXYSTILBAMIDINE ISETHIONATEDiscontinued
HYDROXYSTILBAMIDINE ISETHIONATE 225MG/AMP · INJECTABLE · INJECTION

Approval history

1987-03-19Labeling · Supplement 8 · standardAP
1980-05-12Manufacturing (CMC) · Supplement 7 · standardAP
1980-05-12Labeling · Supplement 6 · standardAP
1980-04-12Manufacturing (CMC) · Supplement 5 · standardAP
1953-12-22Type 3 - New Dosage Form · Original · standardAP
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