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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 207284

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NDA 207284 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 207284

Tradename:	DIFLUPREDNATE
Applicant:	Epic Pharma Llc
Ingredient:	difluprednate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	May 14, 2024	TE:	AB	RLD:	No

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