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Last Updated: February 16, 2020

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Details for New Drug Application (NDA): 205573

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NDA 205573 describes ITRACONAZOLE, which is a drug marketed by Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Anda Repository, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, 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 205573
Applicant:Amneal Pharms
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205573
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ITRACONAZOLE itraconazole SOLUTION;ORAL 205573 ANDA Amneal Pharmaceuticals LLC 65162-087 65162-087-74 150 mL in 1 BOTTLE, GLASS (65162-087-74)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Oct 30, 2015TE:AARLD:No
Regulatory Exclusivity Expiration:Mar 17, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

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