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Last Updated: April 16, 2024

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 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-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:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021131

Medical Subject Heading (MeSH) Categories for 021131

Anti-Bacterial Agents
Protein Synthesis Inhibitors

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:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MG/100ML (2MG/ML)
Approval Date:	Apr 18, 2000	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 18, 2000	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	600MG/300ML (2MG/ML)
Approval Date:	Apr 18, 2000	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021131

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-002	Apr 18, 2000	⤷ Try a Trial	⤷ Try a Trial
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-003	Apr 18, 2000	⤷ Try a Trial	⤷ Try a Trial
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-001	Apr 18, 2000	⤷ Try a Trial	⤷ Try a Trial
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-001	Apr 18, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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