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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200463

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NDA 200463 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 200463
Tradename:ITRACONAZOLE
Applicant:Mylan Pharms Inc
Ingredient:itraconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 200463
Medical Subject Heading (MeSH) Categories for 200463
Suppliers and Packaging for NDA: 200463
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ITRACONAZOLE itraconazole CAPSULE;ORAL 200463 ANDA Mylan Pharmaceuticals Inc. 0378-5100 N 0378-5100-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 20, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Argus Health
Deloitte
Chinese Patent Office
AstraZeneca
Express Scripts
Julphar
Queensland Health
Boehringer Ingelheim

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