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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 076263


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NDA 076263 describes DIFLORASONE DIACETATE, which is a drug marketed by Ani Pharms, Avondale Pharms, Taro, Akorn, Rising, and The J Molner, and is included in eight NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the diflorasone diacetate profile page.
Summary for 076263
Tradename:DIFLORASONE DIACETATE
Applicant:Ani Pharms
Ingredient:diflorasone diacetate
Patents:0
Pharmacology for NDA: 076263
Suppliers and Packaging for NDA: 076263
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFLORASONE DIACETATE diflorasone diacetate CREAM;TOPICAL 076263 ANDA ANI Pharmaceuticals, Inc. 62559-365 62559-365-26 6 TUBE in 1 CARTON (62559-365-26) / 2 g in 1 TUBE
DIFLORASONE DIACETATE diflorasone diacetate CREAM;TOPICAL 076263 ANDA ANI Pharmaceuticals, Inc. 62559-365 62559-365-30 1 TUBE in 1 CARTON (62559-365-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Dec 20, 2002TE:BXRLD:No

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