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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090862

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NDA 090862 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Mylan Pharms Inc, Novel Labs Inc, Alvogen Inc, Sandoz Inc, Xellia Pharms Aps, Ajanta Pharma Ltd, Akorn, Appco Pharma Llc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Prinston Inc, Teva Pharms, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from twenty-seven suppliers. Additional details are available on the VORICONAZOLE profile page.

The generic ingredient in VORICONAZOLE is voriconazole. There are thirteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

Summary for 090862

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 090862

Suppliers and Packaging for NDA: 090862

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VORICONAZOLE voriconazole INJECTABLE;IV (INFUSION) 090862 ANDA Sandoz Inc 0781-3416 0781-3416-94 1 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94) > 20 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength200MG/VIAL
Approval Date:May 30, 2012TE:APRLD:No


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Federal Trade Commission
Queensland Health
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Dow
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Covington

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