APPLICATION
NDA012052
TYPE
NDA
ORIGINAL APPROVAL
1960-06-08
LATEST ACTION
1997-12-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROCORTONE · ReferenceDiscontinued
HYDROCORTISONE SODIUM PHOSPHATE EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1997-12-01Manufacturing (CMC) · Supplement 51 · standardAP
1997-05-02Manufacturing (CMC) · Supplement 49 · standardAP
1997-01-16Manufacturing (CMC) · Supplement 48 · standardAP
1996-03-01Manufacturing (CMC) · Supplement 45 · standardAP
1996-02-29Manufacturing (CMC) · Supplement 44 · standardAP
1993-09-10Manufacturing (CMC) · Supplement 41 · standardAP
1993-08-26Labeling · Supplement 42 · standardAP
1989-09-06Manufacturing (CMC) · Supplement 40 · standardAP
1986-01-15Manufacturing (CMC) · Supplement 32 · standardAP
1985-03-08Labeling · Supplement 34 · standardAP
1984-02-23Labeling · Supplement 33 · standardAP
1982-03-04Manufacturing (CMC) · Supplement 28 · standardAP
1981-10-16Manufacturing (CMC) · Supplement 29 · standardAP
1980-01-14Labeling · Supplement 27 · standardAP
1977-06-27Manufacturing (CMC) · Supplement 25 · standardAP
1960-06-08Type 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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