Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 213674

Expand all

XTANDI (ENZALUTAMIDE)
40MG
Marketing Status: Prescription
Active Ingredient: ENZALUTAMIDE
Proprietary Name: XTANDI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213674
Product Number: 001
Approval Date: Aug 4, 2020
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
XTANDI (ENZALUTAMIDE)
80MG
Marketing Status: Prescription
Active Ingredient: ENZALUTAMIDE
Proprietary Name: XTANDI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213674
Product Number: 002
Approval Date: Aug 4, 2020
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English