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Moodys
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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206799

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NDA 206799 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 fourteen 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 206799
Tradename:VORICONAZOLE
Applicant:Novel Labs Inc
Ingredient:voriconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206799
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VORICONAZOLE voriconazole FOR SUSPENSION;ORAL 206799 ANDA Novel Laboratories, Inc. 40032-038 N 40032-038-60
VORICONAZOLE voriconazole FOR SUSPENSION;ORAL 206799 ANDA Lupin Pharmaceuticals,Inc. 43386-038 N 43386-038-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:May 31, 2016TE:ABRLD:No

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