FDA
Aspirin; Omeprazole
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- ASPIRIN 81MG; OMEPRAZOLE 40MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ASPIRIN 325MG; OMEPRAZOLE 40MG · TabletANDA209791-002 · Tentative approval
- ASPIRIN 81MG; OMEPRAZOLE 40MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA209791.
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
- Aspirin; Omeprazole
- Active substance
- aspirin
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Teva Pharms USA Inc
- Status
- Tentative approval
- FDA approval
- 20 Jan 2023
- Application
- ANDA209791-001