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FDA NDA · NDA009519

DORIDEN

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA009519
TYPE
NDA
ORIGINAL APPROVAL
1957-04-16
LATEST ACTION
1982-03-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET
MARKETING STATUS
Discontinued

Products

DORIDENDiscontinued
GLUTETHIMIDE 500MG · CAPSULE · ORAL
DORIDENDiscontinued
GLUTETHIMIDE 250MG · TABLET · ORAL
DORIDENDiscontinued
GLUTETHIMIDE 500MG · TABLET · ORAL

Approval history

1982-03-15Labeling · Supplement 12AP
1979-08-08Labeling · Supplement 10AP
1976-03-10Labeling · Supplement 7AP
1957-04-16Type 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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