FDA
Darunavir Ethanolate
The FDA lists this product in 3 strengths and forms.
Composition
- Active ingredients
- DARUNAVIR ETHANOLATE 600MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DARUNAVIR ETHANOLATE 400MG · TabletANDA210187-002 · Tentative approval
- DARUNAVIR ETHANOLATE 600MG · TabletThis page
- DARUNAVIR ETHANOLATE 150MG · TabletANDA210187-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA210187.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Darunavir Ethanolate
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Micro Labs USA
- Status
- Tentative approval
- FDA approval
- 14 Dec 2020
- Application
- ANDA210187-003