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Generated: April 28, 2017

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Fluvastatin sodium - Generic Drug Details

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What are the generic sources for fluvastatin sodium and what is the scope of freedom to operate?

Fluvastatin sodium
is the generic ingredient in three branded drugs marketed by Teva Pharms, Teva Pharms Usa, Mylan Pharms Inc, and Novartis, and is included in six NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fluvastatin sodium has twenty-eight patent family members in nineteen countries.

There are eleven drug master file entries for fluvastatin sodium. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: fluvastatin sodium

Drug Master File Entries: see list11
Suppliers / Packagers: see list7
Bulk Api Vendors: see list81
Clinical Trials: see list937
Patent Applications: see list4,712
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluvastatin sodium at DailyMed

Pharmacology for Ingredient: fluvastatin sodium

Tentative approvals for FLUVASTATIN SODIUM

Applicant Application No. Form Dosage
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 2000ABRXYesYes6,242,003*PED► SubscribeY► Subscribe
Mylan Pharms Inc
fluvastatin sodium
CAPSULE;ORAL090595-002Apr 11, 2012ABRXNoNo► Subscribe► Subscribe
Teva Pharms
fluvastatin sodium
CAPSULE;ORAL078407-001Jun 12, 2012ABRXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
fluvastatin sodium
CAPSULE;ORAL090595-001Apr 11, 2012ABRXNoNo► Subscribe► Subscribe
Teva Pharms Usa
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL079011-001Jan 27, 2016ABRXNoNo► Subscribe► Subscribe
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