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Last Updated: June 19, 2021

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Details for New Drug Application (NDA): 021131


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NDA 021131 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 021131
Tradename:ZYVOX
Applicant:Pfizer
Ingredient:linezolid
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021131
Medical Subject Heading (MeSH) Categories for 021131
Suppliers and Packaging for NDA: 021131
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYVOX linezolid SOLUTION;INTRAVENOUS 021131 NDA Pharmacia & Upjohn Company LLC 0009-4992 0009-4992-02 10 BAG in 1 BOX (0009-4992-02) > 300 mL in 1 BAG (0009-4992-01)
ZYVOX linezolid SOLUTION;INTRAVENOUS 021131 NDA Pharmacia & Upjohn Company LLC 0009-5137 0009-5137-04 10 BAG in 1 BOX (0009-5137-04) > 100 mL in 1 BAG (0009-5137-01)
Paragraph IV (Patent) Challenges for 021131
Tradename Dosage Ingredient NDA Submissiondate
ZYVOX SOLUTION;INTRAVENOUS linezolid 021131 2009-12-29
ZYVOX SOLUTION;INTRAVENOUS linezolid 021131 2009-09-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength200MG/100ML (2MG/ML)
Approval Date:Apr 18, 2000TE:APRLD:Yes
Patent:  Get Started FreePatent Expiration:Jul 29, 2021Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 18, 2000TE:RLD:Yes
Patent:  Get Started FreePatent Expiration:Jul 29, 2021Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength600MG/300ML (2MG/ML)
Approval Date:Apr 18, 2000TE:APRLD:Yes
Patent:  Get Started FreePatent Expiration:Jul 29, 2021Product Flag?Substance Flag?Delist Request?Y

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Serving leading biopharmaceutical companies globally:

Medtronic
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Moodys
Colorcon

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