APPLICATION
NDA016199
TYPE
NDA
ORIGINAL APPROVAL
1966-01-12
LATEST ACTION
2014-06-03
ROUTE
RECTAL
DOSAGE FORM
ENEMA
MARKETING STATUS
Prescription
Products
CORTENEMA · ReferencePrescription
HYDROCORTISONE 100MG/60ML · ENEMA · RECTAL
Approval history
2014-06-03Manufacturing (CMC) · Supplement 36 · priorityAP
1996-09-25Manufacturing (CMC) · Supplement 33 · priorityAP
1995-03-22Manufacturing (CMC) · Supplement 32 · priorityAP
1994-11-29Manufacturing (CMC) · Supplement 31 · priorityAP
1993-12-28Manufacturing (CMC) · Supplement 29 · priorityAP
1992-03-24Manufacturing (CMC) · Supplement 27 · priorityAP
1992-02-12Labeling · Supplement 28AP
1992-02-12Labeling · Supplement 30AP
1984-06-04Manufacturing (CMC) · Supplement 22 · priorityAP
1979-12-19Manufacturing (CMC) · Supplement 19 · priorityAP
1979-02-19Labeling · Supplement 15AP
1978-06-19Manufacturing (CMC) · Supplement 18 · priorityAP
1976-12-29Manufacturing (CMC) · Supplement 16 · priorityAP
1966-01-12Type 3 - New Dosage Form · Original · priorityAP
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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