APPLICATION
ANDA086257
TYPE
ANDA
ORIGINAL APPROVAL
1978-07-24
LATEST ACTION
1993-04-29
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
HYDROCORTISONEDiscontinued
HYDROCORTISONE 1% · OINTMENT · TOPICAL
Approval history
1993-04-29Labeling · Supplement 25AP
1992-10-19Labeling · Supplement 24AP
1991-04-16Labeling · Supplement 23AP
1990-11-21Manufacturing (CMC) · Supplement 22AP
1989-07-21Manufacturing (CMC) · Supplement 21AP
1989-02-07Labeling · Supplement 20AP
1988-04-11Labeling · Supplement 18AP
1986-07-24Manufacturing (CMC) · Supplement 15AP
1985-04-08Manufacturing (CMC) · Supplement 12AP
1984-07-03Manufacturing (CMC) · Supplement 7AP
1983-08-26Manufacturing (CMC) · Supplement 8AP
1982-05-24Manufacturing (CMC) · Supplement 6AP
1978-07-24OriginalAP
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.