APPLICATION
NDA017698
TYPE
NDA
ORIGINAL APPROVAL
1976-12-22
LATEST ACTION
1982-06-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
STERILE UREADiscontinued
UREA 40GM/VIAL · INJECTABLE · INJECTION
Approval history
1982-06-11Labeling · Supplement 8 · standardAP
1982-03-08Manufacturing (CMC) · Supplement 9 · standardAP
1980-09-22Manufacturing (CMC) · Supplement 2 · standardAP
1980-09-03Manufacturing (CMC) · Supplement 5 · standardAP
1980-06-25Manufacturing (CMC) · Supplement 4 · standardAP
1980-06-02Manufacturing (CMC) · Supplement 3 · standardAP
1976-12-22Type 6 - New Indication (no longer used) · 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.
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.