APPLICATION
NDA009900
TYPE
NDA
ORIGINAL APPROVAL
1955-05-10
LATEST ACTION
1997-12-01
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
CORTEFDiscontinued
HYDROCORTISONE CYPIONATE EQ 10MG BASE/5ML · SUSPENSION · ORAL
Approval history
1997-12-01Manufacturing (CMC) · Supplement 27 · standardAP
1993-12-28Labeling · Supplement 23AP
1990-08-29Manufacturing (CMC) · Supplement 22 · standardAP
1982-06-30Manufacturing (CMC) · Supplement 18 · standardAP
1979-06-04Labeling · Supplement 16AP
1955-05-10Type 3 - New Dosage Form · Original · standardAP
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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