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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205080

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NDA 205080 describes ITRACONAZOLE, which is a drug marketed by Sandoz, Par Pharm Inc, Alembic Pharms Ltd, Jubilant Generics, Mylan Pharms Inc, Amneal Pharms, Accord Hlthcare, and Alkem Labs Ltd, and is included in nine 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: 205080

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

Pharmacology for NDA: 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 American Health Packaging 60687-299 60687-299-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-299-25) > 1 CAPSULE in 1 BLISTER PACK (60687-299-95)
ITRACONAZOLE
itraconazole
CAPSULE;ORAL 205080 ANDA Amneal Pharmaceuticals of New York, LLC 65162-630 65162-630-03 30 CAPSULE in 1 BOTTLE (65162-630-03)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Fuji
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Teva
Chinese Patent Office
Merck
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US Army
Accenture
Fish and Richardson
Citi

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.

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