Hydrocortisone Acetate

NDA 9637, held by Epic Pharma LLC. Hydrocortisone Acetate.

As of Nov 13, 2026, NDA 9637 (Hydrocortisone Acetate), held by Epic Pharma LLC, was first approved by FDA on Jun 25, 1997, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 25, 1997
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 25, 1997	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Hydrocortisone Acetate25MG/ML · injectable;injection	Hydrocortisone Acetate	Discontinued
Hydrocortisone Acetate50MG/ML · injectable;injection	Hydrocortisone Acetate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 25, 1997	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted
Oct 26, 1981	Supplement 6Labeling	Approved	None posted
Oct 26, 1981	Supplement 5Labeling	Approved	None posted

Identifiers

Application: NDA 9637
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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