Last Updated: September 24, 2026

Details for New Drug Application (NDA): 083767

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NDA 083767 describes PREDNISOLONE ACETATE, which is a drug marketed by Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, Amneal, and Lupin, and is included in eleven 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 083767

Tradename:	PREDNISOLONE ACETATE
Applicant:	Watson Labs
Ingredient:	prednisolone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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