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Last Updated: June 6, 2020

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Details for New Drug Application (NDA): 209460


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NDA 209460 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 209460
Tradename:ITRACONAZOLE
Applicant:Torrent
Ingredient:itraconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 209460
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ITRACONAZOLE itraconazole CAPSULE;ORAL 209460 ANDA Torrent Pharmaceuticals Limited 13668-463 13668-463-05 500 CAPSULE in 1 BOTTLE (13668-463-05)
ITRACONAZOLE itraconazole CAPSULE;ORAL 209460 ANDA Torrent Pharmaceuticals Limited 13668-463 13668-463-30 30 CAPSULE in 1 BOTTLE (13668-463-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 24, 2018TE:ABRLD:No

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