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Details for New Drug Application (NDA): 203415

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NDA 203415 describes XTANDI, which is a drug marketed by Astellas and is included in one NDA. 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 eight 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 NDA: 203415

Tradename:
XTANDI
Applicant:
Astellas
Ingredient:
enzalutamide
Patents:3
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 203415

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XTANDI
enzalutamide
CAPSULE;ORAL 203415 NDA Astellas Pharma US, Inc. 0469-0125 0469-0125-99 1 BOTTLE in 1 CARTON (0469-0125-99) > 120 CAPSULE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Aug 31, 2012TE:RLD:Yes
Patent:7,709,517Patent Expiration:Aug 13, 2027Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Aug 31, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:8,183,274Patent Expiration:May 15, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).


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