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Generated: December 16, 2017

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 eleven 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. Sixteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for 200463

Tradename:1
Applicant:1
Ingredient:1
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 0378-5100-93 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-5100-93)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

UBS
Chinese Patent Office
Dow
Harvard Business School
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Cantor Fitzgerald
QuintilesIMS
Novartis
US Department of Justice

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