Solu-Cortef

NDA 9866, held by Pharmacia And Upjohn. Hydrocortisone Sodium Succinate.

As of Nov 13, 2026, NDA 9866 (Solu-Cortef), held by Pharmacia And Upjohn, was first approved by FDA on Apr 27, 1955, with 41 approved supplements and 0 published complete response letters.

First approved: Apr 27, 1955
Review: Standard
Supplements approved: 41
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 42 submissions below

Date	Submission	Status	Documents
Apr 27, 1955	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

4 strengths and forms


Solu-CortefEQ 100MG BASE/VIAL · injectable;injection	Hydrocortisone Sodium Succinate	RxReference drug
Solu-CortefEQ 250MG BASE/VIAL · injectable;injection	Hydrocortisone Sodium Succinate	RxReference drug
Solu-CortefEQ 500MG BASE/VIAL · injectable;injection	Hydrocortisone Sodium Succinate	RxReference drug
Solu-CortefEQ 1GM BASE/VIAL · injectable;injection	Hydrocortisone Sodium Succinate	RxReference drug

All 42 submissions, including labeling and manufacturing supplements


Jul 10, 2024	Supplement 120Labeling · Standard review	Approved	Label Letter
Jun 5, 2024	Supplement 121Labeling · Standard review	Approved	Letter Label
Dec 20, 2023	Supplement 119Labeling · Standard review	Approved	Letter Label
May 27, 2021	Supplement 115Labeling · Standard review	Approved	Label Letter
Nov 21, 2019	Supplement 113Labeling · Standard review	Approved	Label Letter
Sep 8, 2016	Supplement 105Labeling · Standard review	Approved	Letter Label
Sep 8, 2016	Supplement 98Labeling · Standard review	Approved	Letter Label
Feb 25, 2016	Supplement 108Manufacturing · Standard review	Approved	None posted
Sep 23, 2015	Supplement 90Manufacturing · Standard review	Approved	None posted
Sep 6, 2014	Supplement 92Manufacturing · Standard review	Approved	None posted
Jul 22, 2014	Supplement 101Manufacturing · Standard review	Approved	None posted
Jul 3, 2014	Supplement 104Labeling · Standard review	Approved	Letter Label
Jun 24, 2014	Supplement 103Manufacturing · Standard review	Approved	None posted
Jun 9, 2014	Supplement 102Manufacturing · Standard review	Approved	None posted
Apr 4, 2014	Supplement 95Manufacturing · Standard review	Approved	None posted
Mar 28, 2014	Supplement 99Manufacturing · Standard review	Approved	None posted
Nov 8, 2013	Supplement 96Manufacturing · Standard review	Approved	None posted
Sep 27, 2013	Supplement 97Manufacturing · Standard review	Approved	None posted
Jun 16, 2010	Supplement 80Manufacturing · Standard review	Approved	Label Letter
Sep 1, 2009	Supplement 79Labeling · Standard review	Approved	Letter Label
Sep 1, 2009	Supplement 77Labeling · Standard review	Approved	Letter Label
Oct 21, 2002	Supplement 72Manufacturing · Standard review	Approved	None posted
Apr 4, 2000	Supplement 71Manufacturing · Standard review	Approved	None posted
Nov 25, 1999	Supplement 70Manufacturing · Standard review	Approved	None posted
Dec 6, 1994	Supplement 62Manufacturing · Standard review	Approved	None posted
Sep 15, 1994	Supplement 67Manufacturing · Standard review	Approved	None posted
Mar 25, 1994	Supplement 65Manufacturing · Standard review	Approved	None posted
Dec 28, 1993	Supplement 61Labeling	Approved	None posted
Apr 1, 1991	Supplement 59Manufacturing · Standard review	Approved	None posted
Mar 29, 1990	Supplement 56Manufacturing · Standard review	Approved	None posted
Jan 16, 1990	Supplement 57Manufacturing · Standard review	Approved	None posted
Mar 22, 1989	Supplement 50Labeling	Approved	None posted
May 13, 1988	Supplement 55Manufacturing · Standard review	Approved	None posted
Jul 23, 1987	Supplement 52Manufacturing · Standard review	Approved	None posted
Jul 2, 1987	Supplement 54Manufacturing · Standard review	Approved	None posted
Jul 24, 1985	Supplement 51Labeling	Approved	None posted
Dec 15, 1981	Supplement 47Labeling	Approved	None posted
Dec 15, 1981	Supplement 46Manufacturing · Standard review	Approved	None posted
Apr 14, 1980	Supplement 45Labeling	Approved	None posted
Sep 24, 1979	Supplement 44Manufacturing · Standard review	Approved	None posted
Jun 18, 1979	Supplement 43Manufacturing · Standard review	Approved	None posted
Apr 27, 1955	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 9866
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters