Last Updated: November 13, 2026

Details for New Drug Application (NDA): 084717

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NDA 084717 describes PREDNISOLONE ACETATE, which is a drug marketed by Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, Amneal, Lupin, and Upsher Smith Labs, and is included in twelve NDAs. It is available from four suppliers. Additional details are available on the PREDNISOLONE ACETATE profile page.

The generic ingredient in PREDNISOLONE ACETATE is prednisolone acetate. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.

Summary for 084717

Tradename:	PREDNISOLONE ACETATE
Applicant:	Cent Pharms
Ingredient:	prednisolone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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