General MedicationsORALGeneric
ENZALUTAMIDE
ENZALUTAMIDE
Standard Dose
40MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview ENZALUTAMIDE is listed in Drugs@FDA under application 217322 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ENZALUTAMIDE Form and strength TABLET;ORAL - 40MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2024-09-30 00:00:00.
Structured Monograph
Clinical summary
Approval overview ENZALUTAMIDE is listed in Drugs@FDA under application 217322 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ENZALUTAMIDE Form and strength TABLET;ORAL - 40MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2024-09-30 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.