APPLICATION
ANDA070993
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-17
LATEST ACTION
1991-10-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DROPERIDOLDiscontinued
DROPERIDOL 2.5MG/ML · INJECTABLE · INJECTION
Approval history
1991-10-01Labeling · Supplement 5AP
1986-11-17OriginalAP
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.