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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218256

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NDA 218256 describes PREDNISOLONE ACETATE, which is a drug marketed by Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, Amneal, and Lupin Ltd, 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 are eighty-eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.

Summary for 218256

Tradename:	PREDNISOLONE ACETATE
Applicant:	Amneal
Ingredient:	prednisolone acetate
Patents:	0

Pharmacology for NDA: 218256

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 218256

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISOLONE ACETATE	prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	218256	ANDA	Amneal Pharmaceuticals NY LLC	60219-2550	60219-2550-1	1 BOTTLE, PLASTIC in 1 CARTON (60219-2550-1) / 5 mL in 1 BOTTLE, PLASTIC
PREDNISOLONE ACETATE	prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	218256	ANDA	Amneal Pharmaceuticals NY LLC	60219-2551	60219-2551-1	1 BOTTLE, PLASTIC in 1 CARTON (60219-2551-1) / 10 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Jun 11, 2025	TE:	AB	RLD:	No

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