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Last Updated: October 6, 2022

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. 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 021131
Tradename:ZYVOX
Applicant:Pfizer
Ingredient:linezolid
Patents:0
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength200MG/100ML (2MG/ML)
Approval Date:Apr 18, 2000TE:APRLD:Yes

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(2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 18, 2000TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength600MG/300ML (2MG/ML)
Approval Date:Apr 18, 2000TE:APRLD:Yes

Expired US Patents for NDA 021131

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-001 Apr 18, 2000 See Plans and Pricing See Plans and Pricing
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-003 Apr 18, 2000 See Plans and Pricing See Plans and Pricing
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-002 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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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Merck
AstraZeneca
Medtronic
Johnson and Johnson

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