APPLICATION
ANDA085931
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-28
LATEST ACTION
1997-10-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
A-HYDROCORTDiscontinued
HYDROCORTISONE SODIUM SUCCINATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
1997-10-22Manufacturing (CMC) · Supplement 16AP
1997-07-28Manufacturing (CMC) · Supplement 15AP
1996-01-31Manufacturing (CMC) · Supplement 13AP
1994-06-28Labeling · Supplement 12AP
1989-01-04Manufacturing (CMC) · Supplement 10AP
1986-10-15Manufacturing (CMC) · Supplement 9AP
1982-09-10Manufacturing (CMC) · Supplement 3AP
1982-09-10Manufacturing (CMC) · Supplement 4AP
1978-03-28OriginalAP
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.
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