APPLICATION
ANDA087457
TYPE
ANDA
ORIGINAL APPROVAL
1981-06-23
LATEST ACTION
1992-02-27
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
SYNACORT · ReferenceDiscontinued
HYDROCORTISONE 2.5% · CREAM · TOPICAL
Approval history
1992-02-27Labeling · Supplement 7AP
1987-06-02Manufacturing (CMC) · Supplement 5AP
1983-02-17Manufacturing (CMC) · Supplement 2AP
1983-02-17Manufacturing (CMC) · Supplement 1AP
1981-06-23OriginalAP
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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