Pediapred

Controls severe or incapacitating allergic conditions. NDA 19157, held by Pai Holdings. Prednisolone Sodium Phosphate.

As of Nov 13, 2026, NDA 19157 (Pediapred), held by Pai Holdings, was first approved by FDA on May 28, 1986, with 18 approved supplements and 0 published complete response letters.

First approved: May 28, 1986
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions: 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3.

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
Dec 17, 1998	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter
May 28, 1986	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
PediapredEQ 5MG BASE/5ML · solution;oral	Prednisolone Sodium Phosphate	RxReference drug

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 5, 2024	Supplement 25Labeling · Standard review	Approved	Letter Label
Feb 5, 2018	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 8, 2013	Supplement 20Labeling · Standard review	Approved	Label Letter
Dec 3, 2004	Supplement 18Labeling · Standard review	Approved	Review Letter Label
Jan 3, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 17, 1998	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 17, 1998	Supplement 13Labeling · Standard review	Approved	Letter
Dec 17, 1998	Supplement 12Labeling · Standard review	Approved	Letter
Dec 17, 1998	Supplement 11Labeling · Standard review	Approved	Letter
Jan 21, 1998	Supplement 16Labeling · Standard review	Approved	Review
May 29, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
May 10, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 22, 1993	Supplement 9Labeling · Standard review	Approved	None posted
Nov 8, 1993	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 27, 1989	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 2, 1989	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 31, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 14, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
May 28, 1986	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 19157
Drugs@FDA: Overview at FDA
Company: PAI Holdings LLC

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