Details for New Drug Application (NDA): 079011
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The generic ingredient in FLUVASTATIN SODIUM is fluvastatin sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.
Summary for 079011
Tradename: | FLUVASTATIN SODIUM |
Applicant: | Teva Pharms Usa |
Ingredient: | fluvastatin sodium |
Patents: | 0 |
Pharmacology for NDA: 079011
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Suppliers and Packaging for NDA: 079011
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUVASTATIN SODIUM | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 079011 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7446 | 0093-7446-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-01) |
FLUVASTATIN SODIUM | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 079011 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7446 | 0093-7446-56 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-56) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 80MG BASE | ||||
Approval Date: | Jan 27, 2016 | TE: | AB | RLD: | No |
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