Orange Book product · Brand (NDA)
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
LINEZOLID
At a glance
Jun 18, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 18, 2015
11 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
LINEZOLID
Strength
600MG/300ML (2MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 206473
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2000ZYVOXBrand (NDA)
NDA 021132 · PFIZER
- 2000ZYVOXBrand (NDA)
NDA 021131 · PFIZER
- 2000ZYVOXBrand (NDA)
NDA 021130 · 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.

