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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
US Department of Justice
Fish and Richardson

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203503

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NDA 203503 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 203503
Applicant:Glenmark Pharms Ltd
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 203503
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VORICONAZOLE voriconazole TABLET;ORAL 203503 ANDA American Health Packaging 60687-273 N 60687-273-21
VORICONAZOLE voriconazole TABLET;ORAL 203503 ANDA American Health Packaging 60687-294 N 60687-294-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 2, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 2, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim

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