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Chinese Patent Office
Daiichi Sankyo
Julphar
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Medtronic
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Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205991

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NDA 205991 describes ITRACONAZOLE, which is a drug marketed by Sandoz, Par Pharm Inc, Alembic Pharms Ltd, Jubilant Generics, Mylan Pharms Inc, Zydus Pharms Usa Inc, Amneal Pharms, Accord Hlthcare, and Alkem Labs Ltd, 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 NDA: 205991

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 16729-271-10 30 CAPSULE in 1 BOTTLE (16729-271-10)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Queensland Health
QuintilesIMS
Farmers Insurance
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McKesson
US Department of Justice
Teva
Citi
Argus Health
Baxter

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