Cortef

Controls severe or incapacitating allergic conditions. NDA 8697, held by Pharmacia And Upjohn. Hydrocortisone.

As of Nov 13, 2026, NDA 8697 (Cortef), held by Pharmacia And Upjohn, was first approved by FDA on Dec 15, 1952, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 15, 1952
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hydrocortisone tablets are indicated in the following conditions. 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 Non suppurative 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 11 submissions below

Date	Submission	Status	Documents
Dec 15, 1952	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Cortef10MG · tablet;oral	Hydrocortisone	RxReference drug
Cortef20MG · tablet;oral	Hydrocortisone	RxReference drug
Cortef5MG · tablet;oral	Hydrocortisone	RxReference drug

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 5, 2024	Supplement 40Labeling · Standard review	Approved	Letter Label
Dec 20, 2023	Supplement 38Labeling · Standard review	Approved	Letter Label
Nov 21, 2019	Supplement 36Labeling · Standard review	Approved	Label Letter
Sep 8, 2016	Supplement 32Labeling · Standard review	Approved	Letter Label
Sep 8, 2016	Supplement 33Labeling · Standard review	Approved	Letter Label
Mar 16, 2001	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 28, 1993	Supplement 21Labeling · Standard review	Approved	Label
Dec 8, 1993	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 9, 1983	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 8, 1978	Supplement 14Labeling	Approved	None posted
Dec 15, 1952	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 8697
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