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Generated: February 20, 2018

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 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. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.
Summary for 079011
Applicant:Teva Pharms Usa
Ingredient:fluvastatin sodium
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 N 0093-7446-01
FLUVASTATIN SODIUM fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 079011 ANDA Teva Pharmaceuticals USA, Inc. 0093-7446 N 0093-7446-56

Profile for product number 001

Approval Date:Jan 27, 2016TE:ABRLD:No

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