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Xtandi - enzalutamide

Navigation: NDC > Supplier starting with: A > ASTELLAS PHARMA US, INC.
Field Value
NDC Code: 0469-0125
Proprietary Name: Xtandi
Suffix:
Non-Proprietary Name: enzalutamide
Dosage Form: CAPSULE
Method: ORAL
Original Marketing Date: 31-08-2012
Category Name: NDA
Application Number: NDA203415
Labeler: ASTELLAS PHARMA US, INC.
Substance Name: ENZALUTAMIDE
Active Numerator Strength: 40
Active Ingredient Unit: mg/1
Pharm Classes: Androgen Receptor Inhibitor [EPC],Androgen Receptor Antagonists [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
DEA Schedule: