Orange Book product · Brand (NDA)
NEXIUM
ESOMEPRAZOLE MAGNESIUM
At a glance
Dec 15, 2011
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 2011
14 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ESOMEPRAZOLE MAGNESIUM
Strength
EQ 2.5MG BASE/PACKET
Dosage form
FOR SUSPENSION, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021957
Product number
003
Marketing status
RX
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.
- 2014NEXIUM 24HRBrand (NDA)
NDA 204655 · ASTRAZENECA LP
- 2008NEXIUMBrand (NDA)
NDA 022101 · ASTRAZENECA
- 2001NEXIUMBrand (NDA)
NDA 021153 · 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.
