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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 213674


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NDA 213674 describes XTANDI, which is a drug marketed by Astellas and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XTANDI profile page.

The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.
Summary for 213674
Tradename:XTANDI
Applicant:Astellas
Ingredient:enzalutamide
Patents:4
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 213674
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XTANDI enzalutamide TABLET;ORAL 213674 NDA Astellas Pharma US, Inc. 0469-0625 0469-0625-99 1 BOTTLE in 1 CARTON (0469-0625-99) / 120 TABLET in 1 BOTTLE
XTANDI enzalutamide TABLET;ORAL 213674 NDA Astellas Pharma US, Inc. 0469-0725 0469-0725-60 1 BOTTLE in 1 CARTON (0469-0725-60) / 60 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Aug 4, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 17, 2026
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (NMCSPC) WITH BIOCHEMICAL RECURRENCE AT HIGH RISK FOR METASTASIS
Patent:⤷  Try a TrialPatent Expiration:Sep 11, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Aug 13, 2027Product Flag?YSubstance Flag?YDelist Request?

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