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Fish and Richardson
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021131

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NDA 021131 describes ZYVOX, which is a drug marketed by Pharmacia And Upjohn and is included in three NDAs. It is available from six suppliers. There are two patents protecting this drug and four Paragraph IV challenges. Additional details are available on the ZYVOX profile page.

The generic ingredient in ZYVOX is linezolid. There are twenty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 021131
Tradename:ZYVOX
Applicant:Pharmacia And Upjohn
Ingredient:linezolid
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 021131
Ingredient-typeOxazolidinones
Medical Subject Heading (MeSH) Categories for 021131
Suppliers and Packaging for NDA: 021131
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYVOX linezolid SOLUTION;IV (INFUSION) 021131 NDA Pharmacia and Upjohn Company LLC 0009-4992 N 0009-4992-02
ZYVOX linezolid SOLUTION;IV (INFUSION) 021131 NDA Pharmacia and Upjohn Company LLC 0009-5137 N 0009-5137-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength200MG/100ML (2MG/ML)
Approval Date:Apr 18, 2000TE:APRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 29, 2021Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength400MG/200ML (2MG/ML)
Approval Date:Apr 18, 2000TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 29, 2021Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength600MG/300ML (2MG/ML)
Approval Date:Apr 18, 2000TE:APRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 29, 2021Product Flag?Substance Flag?Delist Request?Y

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