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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Accenture
QuintilesIMS
Julphar
Moodys
Mallinckrodt
Dow
McKinsey
Farmers Insurance

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205991

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NDA 205991 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 205991
Tradename:ITRACONAZOLE
Applicant:Accord Hlthcare
Ingredient:itraconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 205991
Medical Subject Heading (MeSH) Categories for 205991
Suppliers and Packaging for NDA: 205991
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ITRACONAZOLE itraconazole CAPSULE;ORAL 205991 ANDA Accord Healthcare Inc. 16729-271 N 16729-271-10

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Julphar
Farmers Insurance
Daiichi Sankyo
Colorcon
Queensland Health
Moodys
Express Scripts
Cipla

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