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Last Updated: January 17, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021130

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NDA 021130 describes ZYVOX, which is a drug marketed by Pfizer and is included in three NDAs. It is available from five 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. Twenty-four suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 021130
Tradename:ZYVOX
Applicant:Pfizer
Ingredient:linezolid
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021130
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 & 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 & 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
Paragraph IV (Patent) Challenges for 021130
Tradename Dosage Ingredient NDA Submissiondate
ZYVOX TABLET;ORAL linezolid 021130 2005-12-21

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:  Start TrialPatent Expiration:Sep 15, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:  Start 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:  Start TrialPatent Expiration:Sep 15, 2021Product Flag?Substance Flag?Delist Request?Y

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