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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208591


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NDA 208591 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 208591
Tradename:ITRACONAZOLE
Applicant:Alkem Labs Ltd
Ingredient:itraconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 208591
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ITRACONAZOLE itraconazole CAPSULE;ORAL 208591 ANDA NorthStar RxLLC 16714-743 16714-743-01 7 BLISTER PACK in 1 CARTON (16714-743-01) > 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK
ITRACONAZOLE itraconazole CAPSULE;ORAL 208591 ANDA NorthStar RxLLC 16714-743 16714-743-02 30 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-743-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jun 12, 2017TE:ABRLD:No

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