APPLICATION
ANDA088250
TYPE
ANDA
ORIGINAL APPROVAL
1984-06-06
LATEST ACTION
2000-08-11
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
ANUSOL HCPrescription
HYDROCORTISONE 2.5% · CREAM · TOPICAL
Approval history
2000-08-11Manufacturing (CMC) · Supplement 8AP
2000-01-19Manufacturing (CMC) · Supplement 7AP
1998-12-07Manufacturing (CMC) · Supplement 6AP
1998-05-13Manufacturing (CMC) · Supplement 4AP
1998-05-13Manufacturing (CMC) · Supplement 5AP
1997-12-10Manufacturing (CMC) · Supplement 3AP
1993-05-19Labeling · Supplement 2AP
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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