APPLICATION
NDA008917
TYPE
NDA
ORIGINAL APPROVAL
1953-07-28
LATEST ACTION
1990-07-05
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
CORTEF ACETATEDiscontinued
HYDROCORTISONE ACETATE 1% · OINTMENT · TOPICAL
CORTEF ACETATE · ReferenceDiscontinued
HYDROCORTISONE ACETATE 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL
Approval history
1990-07-05Manufacturing (CMC) · Supplement 21 · standardAP
1987-04-28Manufacturing (CMC) · Supplement 18 · standardAP
1987-04-28Manufacturing (CMC) · Supplement 19 · standardAP
1982-10-14Labeling · Supplement 17AP
1980-03-19Labeling · Supplement 16AP
1977-10-11Manufacturing (CMC) · Supplement 14 · standardAP
1977-02-10Manufacturing (CMC) · Supplement 13 · standardAP
1976-10-12Manufacturing (CMC) · Supplement 12 · standardAP
1976-06-03Labeling · Supplement 11AP
1953-07-28Type 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.