Orange Book product · Generic (ANDA)
ESOMEPRAZOLE SODIUM
ESOMEPRAZOLE SODIUM
At a glance
Feb 10, 2022
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 10, 2022
4 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ESOMEPRAZOLE SODIUM
Strength
EQ 40MG BASE/VIAL
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 215732
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of ESOMEPRAZOLE SODIUM
- 2005NEXIUM IVBrand (NDA)
NDA 021689 · ASTRAZENECA
- 2025ESOMEPRAZOLE SODIUMGeneric (ANDA)
ANDA 214046 · EPIC PHARMA LLC
- 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.
