A-Hydrocort

ANDA 85931, held by Hospira. Hydrocortisone Sodium Succinate.

As of Nov 15, 2026, ANDA 85931 (A-Hydrocort), held by Hospira, was first approved by FDA on Mar 28, 1978, with 8 approved supplements and 0 published complete response letters.

First approved: Mar 28, 1978
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Mar 28, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
A-HydrocortEQ 500MG BASE/VIAL · injectable;injection	Hydrocortisone Sodium Succinate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Oct 22, 1997	Supplement 16Manufacturing	Approved	None posted
Jul 28, 1997	Supplement 15Manufacturing	Approved	None posted
Jan 31, 1996	Supplement 13Manufacturing	Approved	None posted
Jun 28, 1994	Supplement 12Labeling	Approved	None posted
Jan 4, 1989	Supplement 10Manufacturing	Approved	None posted
Oct 15, 1986	Supplement 9Manufacturing	Approved	None posted
Sep 10, 1982	Supplement 4Manufacturing	Approved	None posted
Sep 10, 1982	Supplement 3Manufacturing	Approved	None posted
Mar 28, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85931
Drugs@FDA: Overview at FDA
Company: Hospira

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