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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 nine 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-seven suppliers are listed for this compound. Additional details are available on the linezolid profile page.

Summary for NDA: 021130

Tradename:
ZYVOX
Applicant:
Pharmacia And Upjohn
Ingredient:
linezolid
Patents:2
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 021130

Ingredient-typeOxazolidinones

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 0009-5135 0009-5135-01 100 TABLET, FILM COATED in 1 BOTTLE (0009-5135-01)
ZYVOX
linezolid
TABLET;ORAL 021130 NDA Pharmacia and Upjohn Company LLC 0009-5135 0009-5135-02 20 TABLET, FILM COATED in 1 BOTTLE (0009-5135-02)

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Patent:6,514,529*PEDPatent Expiration:Sep 15, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:6,559,305*PEDPatent Expiration:Jul 29, 2021Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Apr 18, 2000TE:ABRLD:Yes
Patent:6,514,529*PEDPatent Expiration:Sep 15, 2021Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021130

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-001Apr 18, 20005,688,792*PED► subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-002Apr 18, 20005,688,792*PED► subscribe
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