APPLICATION
ANDA088799
TYPE
ANDA
ORIGINAL APPROVAL
1984-11-09
LATEST ACTION
2005-07-28
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
HYDROCORTISONEPrescription
HYDROCORTISONE 2.5% · CREAM · TOPICAL
Approval history
2005-07-28Labeling · Supplement 27AP
2005-04-28Labeling · Supplement 30AP
1993-04-29Labeling · Supplement 25AP
1992-11-16Labeling · Supplement 16AP
1992-02-21Labeling · Supplement 14AP
1990-12-17Labeling · Supplement 13AP
1990-03-28Manufacturing (CMC) · Supplement 9AP
1990-03-28Manufacturing (CMC) · Supplement 6AP
1989-07-13Manufacturing (CMC) · Supplement 12AP
1989-07-13Manufacturing (CMC) · Supplement 11AP
1989-05-05Labeling · Supplement 10AP
1986-07-24Manufacturing (CMC) · Supplement 4AP
1985-12-06Manufacturing (CMC) · Supplement 2AP
1985-04-03Manufacturing (CMC) · Supplement 1AP
1984-11-09OriginalAP
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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