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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 218191

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NDA 218191 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 218191

Tradename:	DIFLUPREDNATE
Applicant:	Upsher Smith Labs
Ingredient:	difluprednate
Patents:	0

Suppliers and Packaging for NDA: 218191

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIFLUPREDNATE	difluprednate	EMULSION;OPHTHALMIC	218191	ANDA	Upsher-Smith Laboratories, LLC	0832-6054	0832-6054-05	1 BOTTLE in 1 CARTON (0832-6054-05) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	Feb 11, 2025	TE:	AB	RLD:	No

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