Orange Book product · Generic (ANDA)
ESOMEPRAZOLE SODIUM
ESOMEPRAZOLE SODIUM
At a glance
Apr 01, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 01, 2020
6 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ESOMEPRAZOLE SODIUM
Strength
EQ 20MG BASE/VIAL
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 203349
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
- 2022ESOMEPRAZOLE SODIUMGeneric (ANDA)
ANDA 215732 · SLATE RUN PHARMA
- 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.
