APPLICATION
NDA009659
TYPE
NDA
ORIGINAL APPROVAL
1955-01-19
LATEST ACTION
1977-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCORTISONEDiscontinued
HYDROCORTISONE 10MG · TABLET · ORAL
HYDROCORTISONEDiscontinued
HYDROCORTISONE 20MG · TABLET · ORAL
Approval history
1977-02-09Labeling · Supplement 3AP
1955-01-19Type 5 - New Formulation or New Manufacturer · 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.