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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 075331

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NDA 075331 describes DIFLORASONE DIACETATE, which is a drug marketed by Ani Pharms, Avondale Pharms, Sun Pharma Canada, Rising, Sciegen Pharms Inc, and The J Molner, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the DIFLORASONE DIACETATE profile page.

The generic ingredient in DIFLORASONE DIACETATE is diflorasone diacetate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the diflorasone diacetate profile page.

Summary for 075331

Tradename:	DIFLORASONE DIACETATE
Applicant:	Sun Pharma Canada
Ingredient:	diflorasone diacetate
Patents:	0

Pharmacology for NDA: 075331

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 075331

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIFLORASONE DIACETATE	diflorasone diacetate	OINTMENT;TOPICAL	075331	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1295	51672-1295-1	1 TUBE in 1 CARTON (51672-1295-1) / 15 g in 1 TUBE
DIFLORASONE DIACETATE	diflorasone diacetate	OINTMENT;TOPICAL	075331	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1295	51672-1295-2	1 TUBE in 1 CARTON (51672-1295-2) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.05%
Approval Date:	May 14, 1999	TE:	AB	RLD:	No

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