APPLICATION
NDA017950
TYPE
NDA
ORIGINAL APPROVAL
1978-03-17
LATEST ACTION
2003-03-24
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
WESTCORT · ReferenceDiscontinued
HYDROCORTISONE VALERATE 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
Approval history
1991-11-29Manufacturing (CMC) · Supplement 19 · standardAP
1988-10-04Manufacturing (CMC) · Supplement 18 · standardAP
1986-08-27Manufacturing (CMC) · Supplement 17 · standardAP
1985-08-13Manufacturing (CMC) · Supplement 16 · standardAP
1985-01-03Manufacturing (CMC) · Supplement 15 · standardAP
1984-02-15Manufacturing (CMC) · Supplement 14 · standardAP
1983-10-05Manufacturing (CMC) · Supplement 13 · standardAP
1983-05-06Manufacturing (CMC) · Supplement 12 · standardAP
1983-01-28Labeling · Supplement 9AP
1982-09-08Manufacturing (CMC) · Supplement 8 · standardAP
1982-09-08Manufacturing (CMC) · Supplement 11 · standardAP
1981-08-27Manufacturing (CMC) · Supplement 10 · standardAP
1980-05-14Manufacturing (CMC) · Supplement 6 · standardAP
1980-03-06Manufacturing (CMC) · Supplement 5 · standardAP
1980-01-10Manufacturing (CMC) · Supplement 4 · standardAP
1979-07-03Labeling · Supplement 1AP
1979-04-10Manufacturing (CMC) · Supplement 3 · standardAP
1978-12-11Manufacturing (CMC) · Supplement 2 · standardAP
1978-03-17Type 2 - New Active Ingredient · 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.