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Generated: December 14, 2018

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Details for New Drug Application (NDA): 021132

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NDA 021132 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 021132
Tradename:ZYVOX
Applicant:Pharmacia And Upjohn
Ingredient:linezolid
Patents:1
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 and Upjohn Company LLC 0009-5136 0009-5136-01 240 mL in 1 BOTTLE (0009-5136-01)
ZYVOX linezolid FOR SUSPENSION;ORAL 021132 NDA Department of State Health Services, Pharmacy Branch 55695-009 55695-009-00 240 mL in 1 BOTTLE (55695-009-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength100MG/5ML
Approval Date:Apr 18, 2000TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 29, 2021Product Flag?Substance Flag?Delist Request?Y

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