Orange Book product · Brand (NDA)
NEXIUM IV
ESOMEPRAZOLE SODIUM
At a glance
Mar 31, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 31, 2005
21 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ESOMEPRAZOLE SODIUM
Strength
EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 021689
Product number
002
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.
- 2025ESOMEPRAZOLE SODIUMGeneric (ANDA)
ANDA 214046 · EPIC PHARMA LLC
- 2022ESOMEPRAZOLE SODIUMGeneric (ANDA)
ANDA 215732 · SLATE RUN PHARMA
- 2020ESOMEPRAZOLE SODIUMGeneric (ANDA)
ANDA 203349 · GLAND
- 2017ESOMEPRAZOLE SODIUMGeneric (ANDA)
ANDA 202686 · PHARMOBEDIENT
- 2017ESOMEPRAZOLE SODIUMGeneric (ANDA)
ANDA 207181 · DEVA HOLDING AS
- 2016ESOMEPRAZOLE SODIUMGeneric (ANDA)
ANDA 204657 · EUGIA PHARMA
- 2015ESOMEPRAZOLE SODIUMGeneric (ANDA)
ANDA 205379 · ACCORD HLTHCARE
- 2013ESOMEPRAZOLE SODIUMGeneric (ANDA)
ANDA 200882 · SUN PHARM
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.
