Orange Book product · Generic (ANDA)
ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM
At a glance
Apr 30, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 30, 2024
2 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ESOMEPRAZOLE MAGNESIUM
Strength
EQ 20MG BASE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 207198
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ESOMEPRAZOLE MAGNESIUM
- 2014NEXIUM 24HRBrand (NDA)
NDA 204655 · ASTRAZENECA LP
- 2011NEXIUMBrand (NDA)
NDA 021957 · ASTRAZENECA
- 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
- 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.

