APPLICATION
ANDA087317
TYPE
ANDA
ORIGINAL APPROVAL
1982-06-07
LATEST ACTION
1989-03-08
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued
Products
HYDROCORTISONEDiscontinued
HYDROCORTISONE 0.5% · LOTION · TOPICAL
Approval history
1989-03-08Manufacturing (CMC) · Supplement 4AP
1987-02-04Manufacturing (CMC) · Supplement 2AP
1986-04-01Manufacturing (CMC) · Supplement 1AP
1982-06-07OriginalAP
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.