APPLICATION
ANDA089472
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-13
LATEST ACTION
2013-06-17
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
U-CORTDiscontinued
HYDROCORTISONE ACETATE 1% · CREAM · TOPICAL
Approval history
2013-06-17Labeling · Supplement 23AP
2006-10-04Labeling · Supplement 19AP
2006-06-07Labeling · Supplement 22AP
1997-04-24Labeling · Supplement 8AP
1997-04-24Manufacturing (CMC) · Supplement 7AP
1992-09-11Labeling · Supplement 6AP
1990-04-05Manufacturing (CMC) · Supplement 2AP
1989-10-10Manufacturing (CMC) · Supplement 4AP
1989-01-23Labeling · Supplement 1AP
1988-06-13OriginalAP
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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