Cortisone Acetate

Controls severe or incapacitating allergic conditions. ANDA 80694, held by Chartwell Molecular. Cortisone Acetate.

As of Nov 15, 2026, ANDA 80694 (Cortisone Acetate), held by Chartwell Molecular, was first approved by FDA on Oct 17, 1974, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 17, 1974
Supplements approved: 1
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: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 17, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cortisone Acetate25MG · tablet;oral	Cortisone Acetate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Oct 17, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 80694
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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