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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216935

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NDA 216935 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 216935

Tradename:	PREDNISOLONE ACETATE
Applicant:	Lupin Ltd
Ingredient:	prednisolone acetate
Patents:	0

Pharmacology for NDA: 216935

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 216935

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISOLONE ACETATE	prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	216935	ANDA	A-S Medication Solutions	50090-7539	50090-7539-0	1 BOTTLE in 1 CARTON (50090-7539-0) / 5 mL in 1 BOTTLE
PREDNISOLONE ACETATE	prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	216935	ANDA	Redpharm Drug	67296-2176	67296-2176-5	1 BOTTLE in 1 CARTON (67296-2176-5) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Aug 2, 2024	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Apr 9, 2025
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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