Composition
- Active ingredients
- PRAVASTATIN SODIUM 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- PRAVASTATIN SODIUM 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA019898-008 · Discontinued
- PRAVASTATIN SODIUM 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA019898-004 · Discontinued
- PRAVASTATIN SODIUM 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA019898-002 · Discontinued
- PRAVASTATIN SODIUM 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA019898.
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
- Pravachol
- Active substance
- pravastatin sodium
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Bristol Myers Squibb
- Status
- Discontinued
- FDA approval
- 31 Oct 1991
- Application
- NDA019898-003