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Last Updated: May 24, 2020

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Details for New Drug Application (NDA): 206398


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NDA 206398 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Mylan Pharms Inc, Novel Labs Inc, Alvogen, Gland Pharma Ltd, Hainan Poly Pharm, Sandoz Inc, Zydus Pharms, Xellia Pharms Aps, Ajanta Pharma Ltd, Akorn, Appco, Aurobindo Pharma Ltd, Cadila, Glenmark Pharms Ltd, Prinston Inc, and Teva Pharms, and is included in twenty NDAs. It is available from twenty-four 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-six suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 206398
Tradename:VORICONAZOLE
Applicant:Alvogen
Ingredient:voriconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206398
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VORICONAZOLE voriconazole INJECTABLE;INTRAVENOUS 206398 ANDA Alvogen Inc. 47781-466 47781-466-71 1 VIAL in 1 CARTON (47781-466-71) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength200MG/VIAL
Approval Date:Mar 23, 2016TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

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Moodys

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