Prednisone Intensol

Controls severe or incapacitating allergic conditions. ANDA 88810, held by Hikma. Prednisone.

As of Nov 14, 2026, ANDA 88810 (Prednisone Intensol), held by Hikma, was first approved by FDA on Feb 20, 1985, with 18 approved supplements and 0 published complete response letters.

First approved: Feb 20, 1985
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS Prednisone tablets and solutions 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 19 submissions below

Date	Submission	Status	Documents
Feb 20, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone Intensol5MG/ML · solution;oral	Prednisone	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 30Labeling · Standard review	Approved	None posted
Dec 2, 2020	Supplement 29Manufacturing · Standard review	Approved	None posted
May 4, 2001	Supplement 18Manufacturing	Approved	None posted
Jan 11, 2001	Supplement 17Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 16Manufacturing	Approved	None posted
Jul 13, 1995	Supplement 15Labeling	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
Oct 29, 1993	Supplement 11Manufacturing	Approved	None posted
Jul 10, 1991	Supplement 9Labeling	Approved	None posted
Jul 10, 1991	Supplement 10Labeling	Approved	None posted
Sep 11, 1990	Supplement 6Manufacturing	Approved	None posted
Feb 5, 1990	Supplement 8Labeling	Approved	None posted
Oct 13, 1989	Supplement 7Labeling	Approved	None posted
Jan 24, 1989	Supplement 4Manufacturing	Approved	None posted
Jan 24, 1989	Supplement 5Manufacturing	Approved	None posted
Nov 29, 1988	Supplement 1Bioequivalence	Approved	None posted
Feb 20, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88810
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