Orange Book product · Brand (NDA)
PRILOSEC
OMEPRAZOLE MAGNESIUM
At a glance
Mar 20, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 20, 2008
18 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
OMEPRAZOLE MAGNESIUM
Strength
EQ 2.5MG BASE/PACKET
Dosage form
FOR SUSPENSION, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 022056
Product number
001
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.
- 2003PRILOSEC OTCBrand (NDA)
NDA 021229 · ASTRAZENECA
- 2025OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 218829 · MARKSANS PHARMA
- 2023OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 213201 · AUROBINDO PHARMA LTD
- 2022OMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 216096 · DEXCEL
- 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.
