Orange Book product · Generic (ANDA)
LINEZOLID
LINEZOLID
At a glance
Dec 08, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 08, 2025
6 mo ago
Today
Pharmaceutical detail
Active ingredient
LINEZOLID
Strength
600MG/300ML (2MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 219558
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LINEZOLID
- 2015LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 206473 · HOSPIRA
- 2000ZYVOXBrand (NDA)
NDA 021132 · PFIZER
- 2000ZYVOXBrand (NDA)
NDA 021131 · PFIZER
- 2000ZYVOXBrand (NDA)
NDA 021130 · PFIZER
- 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.
