FDA
Enzalutamide
The FDA lists this product in 10 strengths and forms.
Composition
- Active ingredients
- ENZALUTAMIDE 40MG
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 · CapsuleThis page
- ENZALUTAMIDE 80MG · TabletANDA219675-002 · Tentative approval
- ENZALUTAMIDE 40MG · CapsuleANDA209614-001 · Discontinued
- ENZALUTAMIDE 40MG · CapsuleANDA209667-001 · Discontinued
- ENZALUTAMIDE 80MG · TabletANDA216068-002 · Prescription
- ENZALUTAMIDE 40MG · TabletANDA216068-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA209645.
At a glance
- Brand name
- Enzalutamide
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Apotex
- Status
- Discontinued
- FDA approval
- 22 Apr 2022
- Application
- ANDA209645-001