BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Harvard Business School
US Department of Justice
Federal Trade Commission

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205080

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NDA 205080 describes ITRACONAZOLE, which is a drug marketed by Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, and Zydus Pharms Usa Inc, and is included in ten NDAs. It is available from thirteen suppliers. Additional details are available on the ITRACONAZOLE profile page.

The generic ingredient in ITRACONAZOLE is itraconazole. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for 205080
Applicant:Amneal Pharms
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 205080
Medical Subject Heading (MeSH) Categories for 205080
Suppliers and Packaging for NDA: 205080
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ITRACONAZOLE itraconazole CAPSULE;ORAL 205080 ANDA American Health Packaging 60687-299 N 60687-299-25
ITRACONAZOLE itraconazole CAPSULE;ORAL 205080 ANDA Amneal Pharmaceuticals LLC 65162-630 N 65162-630-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Sep 26, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Queensland Health
Harvard Business School
US Department of Justice

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