You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for New Drug Application (NDA): 021131


✉ Email this page to a colleague

« Back to Dashboard


NDA 021131 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-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
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(2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 5,688,792*PED ⤷  Subscribe
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-003 Apr 18, 2000 6,559,305*PED ⤷  Subscribe
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-002 Apr 18, 2000 6,559,305*PED ⤷  Subscribe
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-001 Apr 18, 2000 6,559,305*PED ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.