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Last Updated: June 22, 2021

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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 Pfizer and is included in three NDAs. It is available from four 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 021132
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 0009-5136-01 240 mL in 1 BOTTLE (0009-5136-01)
ZYVOX linezolid FOR SUSPENSION;ORAL 021132 NDA AUTHORIZED GENERIC Greenstone LLC 59762-1308 59762-1308-1 150 mL in 1 BOTTLE (59762-1308-1)
Paragraph IV (Patent) Challenges for 021132
Tradename Dosage Ingredient NDA Submissiondate
ZYVOX FOR SUSPENSION;ORAL linezolid 021132 2009-08-03

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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