Composition
- Active ingredients
- SEMAGLUTIDE 4MG/3ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SEMAGLUTIDE 8MG/3ML · InjectionANDA220314-003 · Tentative approval
- SEMAGLUTIDE 2MG/3ML · InjectionANDA220314-001 · Tentative approval
- SEMAGLUTIDE 4MG/3ML · InjectionThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA220314.
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
- Semaglutide
- Route
- Solution
- Dosage form
- Injection
- Applicant
- Apotex Inc
- Status
- Tentative approval
- FDA approval
- 7 Apr 2026
- Application
- ANDA220314-002