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Generated: December 14, 2018

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Details for New Drug Application (NDA): 079011

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NDA 079011 describes FLUVASTATIN SODIUM, which is a drug marketed by Mylan Pharms Inc, Teva Pharms, and Teva Pharms Usa, and is included in four NDAs. It is available from three suppliers. Additional details are available on the FLUVASTATIN SODIUM profile page.

The generic ingredient in FLUVASTATIN SODIUM is fluvastatin sodium. There are eleven drug master file entries for this compound. Five 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 079011
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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 80MG BASE
Approval Date:Jan 27, 2016TE:ABRLD:No

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