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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 212566

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NDA 212566 describes DIFLUPREDNATE, which is a drug marketed by Amneal, Caplin, Cipla, Dr Reddys, Epic Pharma Llc, Mylan Labs Ltd, and Upsher Smith Labs, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the DIFLUPREDNATE profile page.

The generic ingredient in DIFLUPREDNATE 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 212566

Tradename:	DIFLUPREDNATE
Applicant:	Mylan Labs Ltd
Ingredient:	difluprednate
Patents:	0

Suppliers and Packaging for NDA: 212566

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIFLUPREDNATE	difluprednate	EMULSION;OPHTHALMIC	212566	ANDA	Mylan Pharmaceuticals Inc.	0378-7518	0378-7518-35	1 BOTTLE in 1 CARTON (0378-7518-35) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	Mar 20, 2025	TE:	AB	RLD:	No

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