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Last Updated: June 29, 2022

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 three 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:3
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:Dec 16, 2022
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)
Patent:See Plans and PricingPatent Expiration:Aug 13, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:See Plans and PricingPatent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

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