APPLICATION
ANDA085025
TYPE
ANDA
ORIGINAL APPROVAL
1983-04-21
LATEST ACTION
1999-12-27
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
HYDROCORTISONEPrescription
HYDROCORTISONE 2.5% · CREAM · TOPICAL
Approval history
1999-12-27Manufacturing (CMC) · Supplement 18AP
1996-05-08Labeling · Supplement 17AP
1996-05-08Manufacturing (CMC) · Supplement 16AP
1986-06-11Manufacturing (CMC) · Supplement 13AP
1983-04-21OriginalAP
1982-06-30Manufacturing (CMC) · Supplement 8AP
1982-06-02Manufacturing (CMC) · Supplement 9AP
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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