Composition
- Active ingredients
- OMEPRAZOLE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- OMEPRAZOLE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Capsule, delayed rel pelletsThis page
- OMEPRAZOLE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Capsule, delayed rel pelletsNDA019810-001 · Discontinued
- OMEPRAZOLE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Capsule, delayed rel pelletsNDA019810-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA019810.
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
- Prilosec
- Active substance
- omeprazole
- Route
- Oral
- Dosage form
- Capsule, delayed rel pellets
- Applicant
- Astrazeneca
- Status
- Discontinued
- FDA approval
- 14 Sept 1989
- Application
- NDA019810-003