FDA
Enzalutamide
The FDA lists this product in 10 strengths and forms.
Composition
- Active ingredients
- ENZALUTAMIDE 80MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ENZALUTAMIDE 40MG · TabletANDA218731-001 · Tentative approval
- ENZALUTAMIDE 80MG · TabletANDA218731-002 · Tentative approval
- ENZALUTAMIDE 80MG · TabletANDA217322-002 · Tentative approval
- ENZALUTAMIDE 40MG · TabletANDA217322-001 · Tentative approval
- ENZALUTAMIDE 40MG · CapsuleANDA209645-001 · Discontinued
- ENZALUTAMIDE 80MG · TabletANDA219675-002 · Tentative approval
- ENZALUTAMIDE 40MG · CapsuleANDA209614-001 · Discontinued
- ENZALUTAMIDE 40MG · CapsuleANDA209667-001 · Discontinued
- ENZALUTAMIDE 80MG · TabletThis page
- ENZALUTAMIDE 40MG · TabletANDA216068-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA216068.
At a glance
- Brand name
- Enzalutamide
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Sandoz
- Status
- Prescription
- FDA approval
- 20 Apr 2026
- Application
- ANDA216068-002