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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 021132


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NDA 021132 describes ZYVOX, which is a drug marketed by Pfizer and is included in three NDAs. It is available from three 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-four suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 021132
Tradename:ZYVOX
Applicant:Pfizer
Ingredient:linezolid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021132
Medical Subject Heading (MeSH) Categories for 021132
Suppliers and Packaging for NDA: 021132
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYVOX linezolid FOR SUSPENSION;ORAL 021132 NDA Pharmacia & Upjohn Company LLC 0009-5136 0009-5136-01 150 mL in 1 BOTTLE (0009-5136-01)
ZYVOX linezolid FOR SUSPENSION;ORAL 021132 NDA Pharmacia & Upjohn Company LLC 0009-5136 0009-5136-04 150 mL in 1 BOTTLE (0009-5136-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength100MG/5ML
Approval Date:Apr 18, 2000TE:ABRLD:Yes

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