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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 206837


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NDA 206837 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hainan Poly, Novel Labs Inc, Rising, Almaject, Aspiro, Eugia Pharma, Gland Pharma Ltd, Meitheal, Norvium Bioscience, Sandoz Inc, Slate Run Pharma, UBI, Xellia Pharms Aps, Zydus Pharms, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Teva Pharms, and is included in twenty-six NDAs. It is available from thirty-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. Thirty-six suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 206837
Tradename:VORICONAZOLE
Applicant:Aurobindo Pharma Ltd
Ingredient:voriconazole
Patents:0
Suppliers and Packaging for NDA: 206837
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VORICONAZOLE voriconazole TABLET;ORAL 206837 ANDA NorthStar Rx LLC 16714-198 16714-198-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-198-01)
VORICONAZOLE voriconazole TABLET;ORAL 206837 ANDA NorthStar Rx LLC 16714-199 16714-199-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-199-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 22, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jan 22, 2016TE:ABRLD:No

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