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Last Updated: April 4, 2026

Details for New Drug Application (NDA): 213774

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NDA 213774 describes DIFLUPREDNATE, which is a drug marketed by Alembic, Amneal, Caplin, Cipla, Dr Reddys, Epic Pharma Llc, Mylan Labs Ltd, and Upsher Smith Labs, and is included in eight NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the difluprednate profile page.

Summary for 213774

Tradename:	DIFLUPREDNATE
Applicant:	Alembic
Ingredient:	difluprednate
Patents:	0

Suppliers and Packaging for NDA: 213774

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIFLUPREDNATE	difluprednate	EMULSION;OPHTHALMIC	213774	ANDA	Alembic Pharmaceuticals Limited	46708-750	46708-750-05	1 BOTTLE in 1 CARTON (46708-750-05) / 5 mL in 1 BOTTLE
DIFLUPREDNATE	difluprednate	EMULSION;OPHTHALMIC	213774	ANDA	Alembic Pharmaceuticals Inc.	62332-750	62332-750-05	1 BOTTLE in 1 CARTON (62332-750-05) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	Jan 26, 2026	TE:	AB	RLD:	No

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