Orange Book product · Brand (NDA)
NEXIUM
ESOMEPRAZOLE MAGNESIUM
At a glance
Feb 20, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 20, 2001
25 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
ESOMEPRAZOLE MAGNESIUM
Strength
EQ 40MG BASE
Dosage form
CAPSULE, DELAYED REL PELLETS
Route
ORAL
TE code
AB
Application
NDA 021153
Product number
002
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.
- 2014NEXIUM 24HRBrand (NDA)
NDA 204655 · ASTRAZENECA LP
- 2011NEXIUMBrand (NDA)
NDA 021957 · ASTRAZENECA
- 2008NEXIUMBrand (NDA)
NDA 022101 · ASTRAZENECA
- 2025ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 218948 · AUROBINDO PHARMA LTD
- 2025ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 219213 · AUROBINDO PHARMA LTD
- 2025ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 212651 · TORRENT
- 2025ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 212652 · TORRENT
- 2025ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 217714 · CIPLA
- 2024ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 208511 · MACLEODS PHARMS LTD
- 2024ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 218092 · GLENMARK SPECLT
- 2024ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 207198 · DR REDDYS
- 2023ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 217022 · ZHEJIANG YONGTAI
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.
