APPLICATION
NDA008506
TYPE
NDA
ORIGINAL APPROVAL
1952-08-05
LATEST ACTION
1996-03-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCORTONEDiscontinued
HYDROCORTISONE 10MG · TABLET · ORAL
HYDROCORTONEDiscontinued
HYDROCORTISONE 20MG · TABLET · ORAL
Approval history
1996-03-01Manufacturing (CMC) · Supplement 25 · priorityAP
1994-05-23Manufacturing (CMC) · Supplement 24 · priorityAP
1993-08-27Labeling · Supplement 22 · standardAP
1989-05-16Labeling · Supplement 16AP
1982-03-02Manufacturing (CMC) · Supplement 15 · priorityAP
1979-08-15Labeling · Supplement 10AP
1979-08-06Labeling · Supplement 11AP
1952-08-05Type 2 New Active Ingredient and Type 4 New Combination · 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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