FDA
Dolutegravir Sodium
The FDA lists this product in 10 strengths and forms.
Composition
- Active ingredients
- DOLUTEGRAVIR SODIUM 50MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DOLUTEGRAVIR SODIUM 50MG · TabletANDA210812-001 · Tentative approval
- DOLUTEGRAVIR SODIUM 50MG · TabletANDA212179-001 · Tentative approval
- DOLUTEGRAVIR SODIUM 50MG · TabletANDA208355-001 · Tentative approval
- DOLUTEGRAVIR SODIUM 50MG · TabletANDA209658-001 · Tentative approval
- DOLUTEGRAVIR SODIUM EQ 25MG BASE · TabletANDA214397-002 · Tentative approval
- DOLUTEGRAVIR SODIUM EQ 50MG BASE · TabletANDA214397-003 · Tentative approval
- DOLUTEGRAVIR SODIUM EQ 10MG BASE · TabletANDA214397-001 · Tentative approval
- DOLUTEGRAVIR SODIUM 50MG · TabletANDA210963-001 · Tentative approval
- DOLUTEGRAVIR SODIUM 50MG · TabletThis page
- DOLUTEGRAVIR SODIUM 10MG · TabletNDA214566-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA209602.
At a glance
- Brand name
- Dolutegravir Sodium
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Mylan Labs LTD
- Status
- Tentative approval
- FDA approval
- 6 Jul 2018
- Application
- ANDA209602-001