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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206762

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NDA 206762 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Mylan Pharms Inc, Novel Labs Inc, Alvogen Inc, Sandoz Inc, Zydus Pharms Usa Inc, Xellia Pharms Aps, Ajanta Pharma Ltd, Akorn, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Prinston Inc, Rising Pharms, and Teva Pharms, and is included in eighteen 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 206762
Applicant:Rising Pharms
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206762
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VORICONAZOLE voriconazole TABLET;ORAL 206762 ANDA APPCO PHARMA LLC 55801-332 55801-332-01 30 TABLET in 1 BOTTLE, PLASTIC (55801-332-01)
VORICONAZOLE voriconazole TABLET;ORAL 206762 ANDA APPCO PHARMA LLC 55801-332 55801-332-02 500 TABLET in 1 BOTTLE, PLASTIC (55801-332-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 24, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 24, 2016TE:ABRLD:No

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