Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Deloitte
Daiichi Sankyo
Accenture
US Department of Justice
Argus Health
Medtronic
Federal Trade Commission
Mallinckrodt

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205080

« Back to Dashboard

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 fourteen 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
Tradename:ITRACONAZOLE
Applicant:Amneal Pharms
Ingredient:itraconazole
Patents:0
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 AvPAK 50268-450 N 50268-450-12
ITRACONAZOLE itraconazole CAPSULE;ORAL 205080 ANDA American Health Packaging 60687-299 N 60687-299-25

Profile for product number 001

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
UBS
Harvard Business School
Chinese Patent Office
QuintilesIMS
Farmers Insurance
Julphar
Daiichi Sankyo
Cipla

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.