APPLICATION
ANDA080426
TYPE
ANDA
ORIGINAL APPROVAL
1971-12-22
LATEST ACTION
1998-10-20
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued
Products
CETACORTDiscontinued
HYDROCORTISONE 0.5% · LOTION · TOPICAL
CETACORTDiscontinued
HYDROCORTISONE 1% · LOTION · TOPICAL
Approval history
1998-10-20Manufacturing (CMC) · Supplement 11AP
1994-07-19Labeling · Supplement 10AP
1992-03-18Labeling · Supplement 9AP
1991-04-23Manufacturing (CMC) · Supplement 7AP
1991-04-23Manufacturing (CMC) · Supplement 8AP
1985-10-29Manufacturing (CMC) · Supplement 6AP
1982-11-04Manufacturing (CMC) · Supplement 4AP
1971-12-22OriginalAP
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.
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