Details for New Drug Application (NDA): 021130

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NDA 021130 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 021130

Tradename:	ZYVOX
Applicant:	Pfizer
Ingredient:	linezolid
Patents:	0

Pharmacology for NDA: 021130

Medical Subject Heading (MeSH) Categories for 021130

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 021130

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZYVOX	linezolid	TABLET;ORAL	021130	NDA	Pharmacia & Upjohn Company LLC	0009-5138	0009-5138-02	20 TABLET, FILM COATED in 1 BOTTLE (0009-5138-02)
ZYVOX	linezolid	TABLET;ORAL	021130	NDA	Pharmacia & Upjohn Company LLC	0009-5138	0009-5138-03	30 BLISTER PACK in 1 BOX, UNIT-DOSE (0009-5138-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Apr 18, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021130

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-001	Apr 18, 2000	⤷ Sign Up	⤷ Sign Up
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000	⤷ Sign Up	⤷ Sign Up
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000	⤷ Sign Up	⤷ Sign Up
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000	⤷ Sign Up	⤷ Sign Up
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-001	Apr 18, 2000	⤷ Sign Up	⤷ Sign Up
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-001	Apr 18, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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