Orange Book product · Generic (ANDA)
OMEPRAZOLE MAGNESIUM
OMEPRAZOLE MAGNESIUM
At a glance
May 24, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 24, 2022
4 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
OMEPRAZOLE MAGNESIUM
Strength
EQ 20MG BASE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 216096
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OMEPRAZOLE MAGNESIUM
- 2008PRILOSECBrand (NDA)
NDA 022056 · AZURITY
- 2003PRILOSEC OTCBrand (NDA)
NDA 021229 · ASTRAZENECA
- 2025OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 218829 · MARKSANS PHARMA
- 2023OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 213201 · AUROBINDO PHARMA LTD
- 2020OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 206582 · P AND L
- 2020OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 211732 · HETERO LABS LTD III
- 2018OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 210593 · SPIL
- 2018OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 206877 · AUROBINDO PHARMA
- 2015OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 204152 · PERRIGO R AND D
- 2009OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 078878 · DR REDDYS LABS LTD
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.
