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Last Updated: June 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204672


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NDA 204672 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, PII, Sandoz, Torrent, Zydus Pharms, and Apotex, and is included in thirteen NDAs. It is available from sixteen 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 204672
Tradename:ITRACONAZOLE
Applicant:Zydus Pharms
Ingredient:itraconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204672
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ITRACONAZOLE itraconazole CAPSULE;ORAL 204672 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-697 68382-697-01 100 CAPSULE in 1 BOTTLE (68382-697-01)
ITRACONAZOLE itraconazole CAPSULE;ORAL 204672 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-697 68382-697-06 30 CAPSULE in 1 BOTTLE (68382-697-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Sep 19, 2017TE:ABRLD:No

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