FDA
Fluvastatin Sodium
The FDA lists this product in 8 strengths and forms.
Composition
- Active ingredients
- FLUVASTATIN SODIUM 80MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- FLUVASTATIN SODIUM EQ 40MG BASE · CapsuleANDA090595-002 · Prescription
- FLUVASTATIN SODIUM EQ 20MG BASE · CapsuleANDA090595-001 · Prescription
- FLUVASTATIN SODIUM EQ 20MG BASE · CapsuleANDA078407-001 · Prescription
- FLUVASTATIN SODIUM EQ 40MG BASE · CapsuleANDA078407-002 · Prescription
- FLUVASTATIN SODIUM EQ 80MG BASE · Tablet, extended releaseANDA209397-001 · Prescription
- FLUVASTATIN SODIUM 80MG · Tablet, extended releaseThis page
- FLUVASTATIN SODIUM EQ 80MG BASE · Tablet, extended releaseANDA202458-001 · Discontinued
- FLUVASTATIN SODIUM EQ 80MG BASE · Tablet, extended releaseANDA079011-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA078872.
At a glance
- Brand name
- Fluvastatin Sodium
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Par Pharm
- Status
- Tentative approval
- FDA approval
- 15 Sept 2009
- Application
- ANDA078872-001