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Last Updated: April 26, 2024

Details for New Drug Application (NDA): 019157

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NDA 019157 describes PEDIAPRED, which is a drug marketed by Seton Pharm 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 are eighty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

Summary for 019157

Tradename:	PEDIAPRED
Applicant:	Seton Pharm
Ingredient:	prednisolone sodium phosphate
Patents:	0
Formulation / Manufacturing:	see details

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	Seton Pharmaceuticals, LLC	13925-166	13925-166-04	120 mL in 1 BOTTLE (13925-166-04)
PEDIAPRED	prednisolone sodium phosphate	SOLUTION;ORAL	019157	NDA	Royal Pharmaceuticals	68791-104	68791-104-04	120 mL in 1 BOTTLE (68791-104-04)

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

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