APPLICATION
NDA018674
TYPE
NDA
ORIGINAL APPROVAL
1982-08-31
LATEST ACTION
1990-06-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METRO I.V.Discontinued
METRONIDAZOLE 500MG/100ML · INJECTABLE · INJECTION
Approval history
1990-06-22Labeling · Supplement 10AP
1989-01-25Labeling · Supplement 9AP
1988-07-08Labeling · Supplement 8AP
1985-02-22Manufacturing (CMC) · Supplement 6AP
1985-02-22Manufacturing (CMC) · Supplement 7AP
1982-08-31OriginalAP
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.