APPLICATION
ANDA088216
TYPE
ANDA
ORIGINAL APPROVAL
1984-06-06
LATEST ACTION
1998-12-09
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
PENECORTDiscontinued
HYDROCORTISONE 1% · CREAM · TOPICAL
Approval history
1998-12-09Manufacturing (CMC) · Supplement 7AP
1998-04-07Manufacturing (CMC) · Supplement 5AP
1997-12-15Manufacturing (CMC) · Supplement 6AP
1988-12-23Manufacturing (CMC) · Supplement 4AP
1985-03-06Manufacturing (CMC) · Supplement 1AP
1984-06-06OriginalAP
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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