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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019828

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NDA 019828 describes OXISTAT, which is a drug marketed by Fougera Pharms and is included in two NDAs. It is available from three suppliers. Additional details are available on the OXISTAT profile page.

The generic ingredient in OXISTAT is oxiconazole nitrate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the oxiconazole nitrate profile page.

Summary for 019828

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antifungals

Pharmacology for NDA: 019828

Ingredient-typeAzoles

Suppliers and Packaging for NDA: 019828

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXISTAT oxiconazole nitrate CREAM;TOPICAL 019828 NDA AUTHORIZED GENERIC E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0358 0168-0358-90 90 g in 1 TUBE (0168-0358-90)
OXISTAT oxiconazole nitrate CREAM;TOPICAL 019828 NDA AUTHORIZED GENERIC E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0358 0168-0358-60 60 g in 1 TUBE (0168-0358-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 1% BASE
Approval Date:Dec 30, 1988TE:ABRLD:Yes


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Serving leading biopharmaceutical companies globally:

Merck
Deloitte
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Dow
AstraZeneca
Fish and Richardson
Express Scripts
Fuji
Chinese Patent Office
US Army

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