APPLICATION
ANDA086619
TYPE
ANDA
ORIGINAL APPROVAL
1981-05-28
LATEST ACTION
1988-05-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROCORTISONE SODIUM SUCCINATEDiscontinued
HYDROCORTISONE SODIUM SUCCINATE EQ 100MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
1988-05-05Labeling · Supplement 11AP
1987-01-13Manufacturing (CMC) · Supplement 10AP
1987-01-13Manufacturing (CMC) · Supplement 9AP
1985-12-17Manufacturing (CMC) · Supplement 5AP
1983-02-01Manufacturing (CMC) · Supplement 3AP
1981-05-28OriginalAP
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.