Last Updated: September 24, 2026

Details for New Drug Application (NDA): 075117

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NDA 075117 describes ORAPRED, which is a drug marketed by Concordia Pharms Inc and Advanz Pharma and is included in two NDAs. Additional details are available on the ORAPRED profile page.

The generic ingredient in ORAPRED 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 075117

Tradename:	ORAPRED
Applicant:	Concordia Pharms Inc
Ingredient:	prednisolone sodium phosphate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 15MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 14, 2000	TE:		RLD:	No

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