APPLICATION
NDA012095
TYPE
NDA
ORIGINAL APPROVAL
1961-06-22
LATEST ACTION
2000-04-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ORINASE DIAGNOSTICDiscontinued
TOLBUTAMIDE SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2000-04-04Manufacturing (CMC) · Supplement 17 · priorityAP
1995-02-01Manufacturing (CMC) · Supplement 16 · priorityAP
1983-06-21Labeling · Supplement 15 · priorityAP
1961-06-22Type 2 - New Active Ingredient · Original · priorityAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.