Composition
- Active ingredients
- SIMVASTATIN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- SIMVASTATIN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
- SIMVASTATIN 20MG · TabletNDA019766-003 · Prescription
- SIMVASTATIN 5MG · TabletNDA019766-001 · Prescription
- SIMVASTATIN 40MG · TabletNDA019766-004 · Prescription
- SIMVASTATIN 10MG · TabletNDA019766-002 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA019766.
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
- Zocor
- Active substance
- simvastatin
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Organon
- Status
- Discontinued
- FDA approval
- 23 Dec 1991
- Application
- NDA019766-005