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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

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. Nineteen 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
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)
Paragraph IV (Patent) Challenges for 019157
Tradename Dosage Ingredient NDA Submissiondate
PEDIAPRED SOLUTION;ORAL prednisolone sodium phosphate 019157

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 5MG BASE/5ML
Approval Date:May 28, 1986TE:AARLD:Yes

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