Last Updated: September 28, 2026

Details for New Drug Application (NDA): 019157

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NDA 019157 describes PEDIAPRED, which is a drug marketed by Pai Holdings and is included in one NDA. It is available from two suppliers. Additional details are available on the PEDIAPRED profile page.

The generic ingredient in PEDIAPRED is prednisolone sodium phosphate. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

Summary for 019157

Tradename:	PEDIAPRED
Applicant:	Pai Holdings
Ingredient:	prednisolone sodium phosphate
Patents:	0

Pharmacology for NDA: 019157

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 019157

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PEDIAPRED	prednisolone sodium phosphate	SOLUTION;ORAL	019157	NDA	PAI Holdings, LLC dba PAI Pharma	0121-1100	0121-1100-04	5 mL in 1 BOTTLE (0121-1100-04)
PEDIAPRED	prednisolone sodium phosphate	SOLUTION;ORAL	019157	NDA	Seton Pharmaceuticals, LLC	13925-166	13925-166-04	120 mL in 1 BOTTLE (13925-166-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 5MG BASE/5ML
Approval Date:	May 28, 1986	TE:	AA	RLD:	Yes

Expired US Patents for NDA 019157

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pai Holdings	PEDIAPRED	prednisolone sodium phosphate	SOLUTION;ORAL	019157-001	May 28, 1986	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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