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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205724


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NDA 205724 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, Strides Pharma, Torrent, Zydus Pharms, Annora Pharma, and Apotex, and is included in fourteen NDAs. It is available from seventeen 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. Twenty-one suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for 205724
Tradename:ITRACONAZOLE
Applicant:Par Pharm Inc
Ingredient:itraconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205724
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ITRACONAZOLE itraconazole CAPSULE;ORAL 205724 ANDA Par Pharmaceutical, Inc. 49884-239 49884-239-11 30 CAPSULE in 1 BOTTLE (49884-239-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 13, 2016TE:ABRLD:No

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