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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 022212

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NDA 022212 describes DUREZOL, which is a drug marketed by Sandoz and is included in one NDA. It is available from one supplier. Additional details are available on the DUREZOL profile page.

The generic ingredient in DUREZOL is difluprednate. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the difluprednate profile page.

Summary for 022212

Tradename:	DUREZOL
Applicant:	Sandoz
Ingredient:	difluprednate
Patents:	0

Suppliers and Packaging for NDA: 022212

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DUREZOL	difluprednate	EMULSION;OPHTHALMIC	022212	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-6000	0781-6000-78	1 BOTTLE in 1 CARTON (0781-6000-78) / 5 mL in 1 BOTTLE
DUREZOL	difluprednate	EMULSION;OPHTHALMIC	022212	NDA	Sandoz Inc	66758-086	66758-086-75	1 BOTTLE in 1 CARTON (66758-086-75) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	Jun 23, 2008	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022212

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	DUREZOL	difluprednate	EMULSION;OPHTHALMIC	022212-001	Jun 23, 2008	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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