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Generated: October 22, 2018

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Details for New Drug Application (NDA): 075187

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NDA 075187 describes DIFLORASONE DIACETATE, which is a drug marketed by Fougera Pharms, Taro, Akorn, Rising Pharms, and Teligent Pharma Inc, and is included in eight NDAs. It is available from nine 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. Nine suppliers are listed for this compound. Additional details are available on the diflorasone diacetate profile page.
Summary for 075187
Tradename:DIFLORASONE DIACETATE
Applicant:Fougera Pharms
Ingredient:diflorasone diacetate
Patents:0
Pharmacology for NDA: 075187
Suppliers and Packaging for NDA: 075187
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFLORASONE DIACETATE diflorasone diacetate CREAM;TOPICAL 075187 ANDA E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. 0168-0242 0168-0242-15 15 g in 1 TUBE (0168-0242-15)
DIFLORASONE DIACETATE diflorasone diacetate CREAM;TOPICAL 075187 ANDA E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. 0168-0242 0168-0242-30 30 g in 1 TUBE (0168-0242-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength0.05%
Approval Date:Mar 30, 1998TE:RLD:No

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