Prednisone

Controls severe or incapacitating allergic conditions. ANDA 80352, held by Hikma. Prednisone.

As of Nov 14, 2026, ANDA 80352 (Prednisone), held by Hikma, was first approved by FDA on Apr 21, 1972, with 22 approved supplements and 0 published complete response letters.

First approved: Apr 21, 1972
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS Prednisone 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 Hypercalcemia associated with cancer Nonsuppurative thyroiditis 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Apr 21, 1972	Original application	Approved	None posted

Products

6 strengths and forms


Prednisone5MG · tablet;oral	Prednisone	RxReference drug
Prednisone1MG · tablet;oral	Prednisone	RxReference drug
Prednisone2.5MG · tablet;oral	Prednisone	RxReference drug
Prednisone10MG · tablet;oral	Prednisone	RxReference drug
Prednisone20MG · tablet;oral	Prednisone	RxReference drug
Prednisone50MG · tablet;oral	Prednisone	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 74Labeling · Standard review	Approved	None posted
May 16, 2024	Supplement 69Labeling · Standard review	Approved	None posted
Nov 24, 2008	Supplement 63Labeling	Approved	None posted
Jun 9, 1997	Supplement 51Manufacturing	Approved	None posted
Jun 9, 1997	Supplement 50Manufacturing	Approved	None posted
Jun 9, 1997	Supplement 48Manufacturing	Approved	None posted
Jun 9, 1997	Supplement 47Manufacturing	Approved	None posted
Mar 11, 1997	Supplement 53Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 52Manufacturing	Approved	None posted
Jul 13, 1995	Supplement 49Labeling	Approved	None posted
Feb 22, 1995	Supplement 46Labeling	Approved	None posted
Oct 7, 1994	Supplement 45Labeling	Approved	None posted
Mar 30, 1994	Supplement 43Labeling	Approved	None posted
Jun 7, 1991	Supplement 42Labeling	Approved	None posted
May 15, 1991	Supplement 41Labeling	Approved	None posted
Dec 26, 1989	Supplement 39Labeling	Approved	None posted
Oct 13, 1989	Supplement 38Labeling	Approved	None posted
Sep 22, 1988	Supplement 37Manufacturing	Approved	None posted
Sep 22, 1988	Supplement 36Manufacturing	Approved	None posted
Sep 2, 1988	Supplement 31Bioequivalence	Approved	None posted
Feb 21, 1984	Supplement 30Manufacturing	Approved	None posted
Apr 6, 1982	Supplement 28Manufacturing	Approved	None posted
Apr 21, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80352
Drugs@FDA: Overview at FDA
Company: Hikma

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