APPLICATION
NDA018719
TYPE
NDA
ORIGINAL APPROVAL
1984-12-31
LATEST ACTION
1993-07-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
MODRASTANEDiscontinued
TRILOSTANE 30MG · CAPSULE · ORAL
MODRASTANEDiscontinued
TRILOSTANE 60MG · CAPSULE · ORAL
Approval history
1993-07-16Labeling · Supplement 5 · standardAP
1993-01-08Labeling · Supplement 4 · standardAP
1985-07-23Labeling · Supplement 2AP
1984-12-31Type 1 - New Molecular Entity · Original · standardAP
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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