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Last Updated: May 21, 2022

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 four suppliers. 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-five 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:0
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

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 18, 2000TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Apr 18, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021130

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 See Plans and Pricing See Plans and Pricing
Pfizer ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 See Plans and Pricing See Plans and Pricing
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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