← FDA DRUG APPROVALS

FDA NDA · NDA009866

SOLU-CORTEF

hydrocortisone sodium succinate

Sponsor: PHARMACIA AND UPJOHN

APPLICATION
NDA009866
TYPE
NDA
ORIGINAL APPROVAL
1955-04-27
LATEST ACTION
2024-07-10
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SOLU-CORTEF · ReferencePrescription
HYDROCORTISONE SODIUM SUCCINATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
SOLU-CORTEF · ReferencePrescription
HYDROCORTISONE SODIUM SUCCINATE EQ 100MG BASE/VIAL · INJECTABLE · INJECTION
SOLU-CORTEF · ReferencePrescription
HYDROCORTISONE SODIUM SUCCINATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
SOLU-CORTEF · ReferencePrescription
HYDROCORTISONE SODIUM SUCCINATE EQ 250MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2024-07-10Labeling · Supplement 120 · standard — Label ↗AP
2024-06-05Labeling · Supplement 121 · standard — Label ↗AP
2023-12-20Labeling · Supplement 119 · standard — Label ↗AP
2021-05-27Labeling · Supplement 115 · standard — Letter ↗AP
2019-11-21Labeling · Supplement 113 · standard — Label ↗AP
2016-09-08Labeling · Supplement 105 · standard — Letter ↗AP
2016-09-08Labeling · Supplement 98 · standard — Letter ↗AP
2016-02-25Manufacturing (CMC) · Supplement 108 · standardAP
2015-09-23Manufacturing (CMC) · Supplement 90 · standardAP
2014-09-06Manufacturing (CMC) · Supplement 92 · standardAP
2014-07-22Manufacturing (CMC) · Supplement 101 · standardAP
2014-07-03Labeling · Supplement 104 · standard — Letter ↗AP
2014-06-24Manufacturing (CMC) · Supplement 103 · standardAP
2014-06-09Manufacturing (CMC) · Supplement 102 · standardAP
2014-04-04Manufacturing (CMC) · Supplement 95 · standardAP
2014-03-28Manufacturing (CMC) · Supplement 99 · standardAP
2013-11-08Manufacturing (CMC) · Supplement 96 · standardAP
2013-09-27Manufacturing (CMC) · Supplement 97 · standardAP
2010-06-16Manufacturing (CMC) · Supplement 80 · standard — Letter ↗AP
2009-09-01Labeling · Supplement 79 · standard — Label ↗AP
2009-09-01Labeling · Supplement 77 · standard — Letter ↗AP
2002-10-21Manufacturing (CMC) · Supplement 72 · standardAP
2000-04-04Manufacturing (CMC) · Supplement 71 · standardAP
1999-11-25Manufacturing (CMC) · Supplement 70 · standardAP
1994-12-06Manufacturing (CMC) · Supplement 62 · standardAP
1994-09-15Manufacturing (CMC) · Supplement 67 · standardAP
1994-03-25Manufacturing (CMC) · Supplement 65 · standardAP
1993-12-28Labeling · Supplement 61AP
1991-04-01Manufacturing (CMC) · Supplement 59 · standardAP
1990-03-29Manufacturing (CMC) · Supplement 56 · standardAP
1990-01-16Manufacturing (CMC) · Supplement 57 · standardAP
1989-03-22Labeling · Supplement 50AP
1988-05-13Manufacturing (CMC) · Supplement 55 · standardAP
1987-07-23Manufacturing (CMC) · Supplement 52 · standardAP
1987-07-02Manufacturing (CMC) · Supplement 54 · standardAP
1985-07-24Labeling · Supplement 51AP
1981-12-15Labeling · Supplement 47AP
1981-12-15Manufacturing (CMC) · Supplement 46 · standardAP
1980-04-14Labeling · Supplement 45AP
1979-09-24Manufacturing (CMC) · Supplement 44 · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →