Prednisone

Controls severe or incapacitating allergic conditions. ANDA 88703, held by Hikma. Prednisone.

As of Nov 14, 2026, ANDA 88703 (Prednisone), held by Hikma, was first approved by FDA on Nov 8, 1984, with 22 approved supplements and 0 published complete response letters.

First approved: Nov 8, 1984
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Prednisone tablets and solutions are indicated in the following conditions: 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.

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
Nov 8, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone5MG/5ML · solution;oral	Prednisone	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 32Labeling · Standard review	Approved	None posted
May 16, 2024	Supplement 31Labeling · Standard review	Approved	None posted
Nov 27, 2002	Supplement 25Manufacturing	Approved	None posted
Nov 27, 2002	Supplement 24Labeling	Approved	None posted
Nov 19, 1999	Supplement 22Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 23Manufacturing	Approved	None posted
Jan 15, 1998	Supplement 20Manufacturing	Approved	None posted
Jan 15, 1998	Supplement 19Manufacturing	Approved	None posted
Dec 13, 1996	Supplement 16Labeling	Approved	None posted
Dec 13, 1996	Supplement 15Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 18Manufacturing	Approved	None posted
Jul 13, 1995	Supplement 17Labeling	Approved	None posted
Feb 22, 1995	Supplement 14Labeling	Approved	None posted
Oct 7, 1994	Supplement 13Labeling	Approved	None posted
Mar 30, 1994	Supplement 12Labeling	Approved	None posted
Jun 15, 1992	Supplement 10Manufacturing	Approved	None posted
Jun 5, 1991	Supplement 11Labeling	Approved	None posted
Feb 21, 1990	Supplement 9Labeling	Approved	None posted
Oct 13, 1989	Supplement 8Labeling	Approved	None posted
May 11, 1988	Supplement 6Manufacturing	Approved	None posted
May 11, 1988	Supplement 5Manufacturing	Approved	None posted
Feb 23, 1988	Supplement 4Labeling	Approved	None posted
Nov 8, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88703
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