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Serving 500+ biopharmaceutical companies globally:

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Federal Trade Commission
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Generated: July 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079011

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

Summary for NDA: 079011

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
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)

Summary 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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Serving 500+ biopharmaceutical companies globally:

Novartis
Julphar
Harvard Business School
Mallinckrodt
UBS
Medtronic
Chinese Patent Office
Daiichi Sankyo
Cerilliant
Covington

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