Orange Book product · Brand (NDA)
ZYVOX
LINEZOLID
At a glance
Apr 18, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 18, 2000
26 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
LINEZOLID
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021130
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2015LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 206473 · HOSPIRA
- 2000ZYVOXBrand (NDA)
NDA 021132 · PFIZER
- 2000ZYVOXBrand (NDA)
NDA 021131 · PFIZER
- 2025LINEZOLIDGeneric (ANDA)
ANDA 219558 · CAPLIN
- 2024LINEZOLIDGeneric (ANDA)
ANDA 210378 · MACLEODS PHARMS LTD
- 2022LINEZOLIDGeneric (ANDA)
ANDA 211813 · HETERO LABS
- 2022LINEZOLIDGeneric (ANDA)
ANDA 206454 · HIKMA
- 2019LINEZOLIDGeneric (ANDA)
ANDA 210702 · CHARTWELL RX
- 2017LINEZOLIDGeneric (ANDA)
ANDA 205154 · PHARMOBEDIENT
- 2017LINEZOLIDGeneric (ANDA)
ANDA 207001 · HQ SPCLT PHARMA
- 2017LINEZOLIDGeneric (ANDA)
ANDA 204696 · SAGENT PHARMS INC
- 2017LINEZOLIDGeneric (ANDA)
ANDA 206097 · ZYDUS PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
