APPLICATION
ANDA089414
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-16
LATEST ACTION
1997-04-01
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
HYDROCORTISONEPrescription
HYDROCORTISONE 2.5% · CREAM · TOPICAL
Approval history
1997-04-01Labeling · Supplement 6AP
1996-03-07Manufacturing (CMC) · Supplement 5AP
1995-11-08Manufacturing (CMC) · Supplement 3AP
1995-11-08Labeling · Supplement 4AP
1986-12-16OriginalAP
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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