APPLICATION
ANDA089066
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-25
LATEST ACTION
2007-11-28
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued
Products
STIE-CORTDiscontinued
HYDROCORTISONE 1% · LOTION · TOPICAL
Approval history
2007-11-28Labeling · Supplement 13AP
2001-08-16Manufacturing (CMC) · Supplement 12AP
1998-08-03Manufacturing (CMC) · Supplement 11AP
1996-02-22Manufacturing (CMC) · Supplement 10AP
1995-04-14Manufacturing (CMC) · Supplement 9AP
1986-05-14Manufacturing (CMC) · Supplement 1AP
1986-05-14Manufacturing (CMC) · Supplement 2AP
1986-04-11Manufacturing (CMC) · Supplement 4AP
1985-11-25OriginalAP
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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