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Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021130

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NDA 021130 describes ZYVOX, which is a drug marketed by Pharmacia And Upjohn and is included in three NDAs. It is available from seven 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 021130
Tradename:ZYVOX
Applicant:Pharmacia And Upjohn
Ingredient:linezolid
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021130
Ingredient-typeOxazolidinones
Medical Subject Heading (MeSH) Categories for 021130
Suppliers and Packaging for NDA: 021130
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYVOX linezolid TABLET;ORAL 021130 NDA Pharmacia and Upjohn Company LLC 0009-5138 0009-5138-02 20 TABLET, FILM COATED in 1 BOTTLE (0009-5138-02)
ZYVOX linezolid TABLET;ORAL 021130 NDA Pharmacia and Upjohn Company LLC 0009-5138 0009-5138-03 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0009-5138-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 18, 2000TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Sep 15, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jul 29, 2021Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Apr 18, 2000TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Sep 15, 2021Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021130

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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US Army
McKesson
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Medtronic
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