APPLICATION
ANDA089074
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-26
LATEST ACTION
2007-11-28
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Prescription
Products
STIE-CORTPrescription
HYDROCORTISONE 2.5% · LOTION · TOPICAL
Approval history
2007-11-28Labeling · Supplement 15AP
2001-08-16Manufacturing (CMC) · Supplement 14AP
1998-08-03Manufacturing (CMC) · Supplement 13AP
1996-01-17Labeling · Supplement 9AP
1996-01-17Manufacturing (CMC) · Supplement 10AP
1995-09-14Manufacturing (CMC) · Supplement 12AP
1995-09-14Manufacturing (CMC) · Supplement 7AP
1995-09-14Labeling · Supplement 8AP
1995-04-14Manufacturing (CMC) · Supplement 11AP
1986-05-14Manufacturing (CMC) · Supplement 1AP
1986-05-14Manufacturing (CMC) · Supplement 2AP
1986-04-11Manufacturing (CMC) · Supplement 4AP
1985-11-26OriginalAP
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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