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Generated: May 25, 2017

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Details for New Drug Application (NDA): 206572

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NDA 206572 describes DIFLORASONE DIACETATE, which is a drug marketed by Taro, Riconpharma Llc, Fougera Pharms, and Akorn, and is included in seven NDAs. It is available from seven 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. Seven suppliers are listed for this compound. Additional details are available on the diflorasone diacetate profile page.

Summary for NDA: 206572

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)

Pharmacology for NDA: 206572

Suppliers and Packaging for NDA: 206572

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
diflorasone diacetate
OINTMENT;TOPICAL 206572 ANDA VersaPharm Incorporated 61748-350 61748-350-15 1 TUBE in 1 CARTON (61748-350-15) > 15 g in 1 TUBE
diflorasone diacetate
OINTMENT;TOPICAL 206572 ANDA VersaPharm Incorporated 61748-350 61748-350-30 1 TUBE in 1 CARTON (61748-350-30) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Jul 24, 2015TE:ABRLD:No

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