Hydrocortisone Sodium Succinate

ANDA 86619, held by Baxter Hlthcare. Hydrocortisone Sodium Succinate.

As of Nov 15, 2026, ANDA 86619 (Hydrocortisone Sodium Succinate), held by Baxter Hlthcare, was first approved by FDA on May 28, 1981, with 5 approved supplements and 0 published complete response letters.

First approved: May 28, 1981
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 28, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone Sodium SuccinateEQ 100MG BASE/VIAL · injectable;injection	Hydrocortisone Sodium Succinate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 5, 1988	Supplement 11Labeling	Approved	None posted
Jan 13, 1987	Supplement 9Manufacturing	Approved	None posted
Jan 13, 1987	Supplement 10Manufacturing	Approved	None posted
Dec 17, 1985	Supplement 5Manufacturing	Approved	None posted
Feb 1, 1983	Supplement 3Manufacturing	Approved	None posted
May 28, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 86619
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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