APPLICATION
ANDA083365
TYPE
ANDA
ORIGINAL APPROVAL
1973-06-18
LATEST ACTION
2024-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCORTISONEDiscontinued
HYDROCORTISONE 20MG · TABLET · ORAL
HYDROCORTISONEDiscontinued
HYDROCORTISONE 5MG · TABLET · ORAL
HYDROCORTISONEDiscontinued
HYDROCORTISONE 10MG · TABLET · ORAL
Approval history
2024-11-26Labeling · Supplement 47 · standardAP
2024-11-26Labeling · Supplement 48 · standardAP
2017-06-28Labeling · Supplement 45 · standardAP
2017-06-28Labeling · Supplement 43 · standardAP
2017-06-28Labeling · Supplement 41 · standardAP
2017-06-28Labeling · Supplement 46 · standardAP
2015-02-23Labeling · Supplement 40AP
2015-02-13Labeling · Supplement 42 · standardAP
2002-07-15Manufacturing (CMC) · Supplement 36AP
2002-01-16Manufacturing (CMC) · Supplement 35AP
2000-08-01Manufacturing (CMC) · Supplement 34AP
1999-01-21Manufacturing (CMC) · Supplement 33AP
1998-10-01Manufacturing (CMC) · Supplement 32AP
1997-11-07Manufacturing (CMC) · Supplement 31AP
1995-06-08Labeling · Supplement 30AP
1994-05-23Labeling · Supplement 29AP
1994-04-22Manufacturing (CMC) · Supplement 28AP
1991-04-03Manufacturing (CMC) · Supplement 22AP
1991-04-03Manufacturing (CMC) · Supplement 23AP
1991-03-05Labeling · Supplement 24AP
1990-04-09Labeling · Supplement 49AP
1990-04-09Labeling · Supplement 19AP
1988-10-14Manufacturing (CMC) · Supplement 14AP
1988-10-14Manufacturing (CMC) · Supplement 18AP
1988-10-14Manufacturing (CMC) · Supplement 16AP
1988-01-07Manufacturing (CMC) · Supplement 20AP
1986-12-05Manufacturing (CMC) · Supplement 17AP
1985-11-13Manufacturing (CMC) · Supplement 10AP
1985-11-13Manufacturing (CMC) · Supplement 11AP
1982-07-13Manufacturing (CMC) · Supplement 9AP
1982-07-13Manufacturing (CMC) · Supplement 5AP
1973-06-18OriginalAP
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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