Orange Book product · Brand (NDA)
PRILOSEC
OMEPRAZOLE
At a glance
Jan 15, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 15, 1998
28 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
OMEPRAZOLE
Strength
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE, DELAYED REL PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 019810
Product number
002
Marketing status
DISCN
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.
- 2017OMEPRAZOLEBrand (NDA)
NDA 209400 · DEXCEL
- 2007OMEPRAZOLEBrand (NDA)
NDA 022032 · DEXCEL PHARMA
- 2020OMEPRAZOLEGeneric (ANDA)
ANDA 212977 · XIROMED
- 2019OMEPRAZOLEGeneric (ANDA)
ANDA 204012 · HETERO LABS LTD III
- 2019OMEPRAZOLEGeneric (ANDA)
ANDA 210070 · APOTEX
- 2018OMEPRAZOLEGeneric (ANDA)
ANDA 207740 · DR REDDYS
- 2018OMEPRAZOLEGeneric (ANDA)
ANDA 207891 · SUN PHARM
- 2018OMEPRAZOLEGeneric (ANDA)
ANDA 205070 · PHARMOBEDIENT
- 2017OMEPRAZOLEGeneric (ANDA)
ANDA 203481 · BRECKENRIDGE
- 2017OMEPRAZOLEGeneric (ANDA)
ANDA 204661 · TEVA PHARMS USA
- 2015OMEPRAZOLEGeneric (ANDA)
ANDA 202384 · LUPIN
- 2015OMEPRAZOLEGeneric (ANDA)
ANDA 203270 · AUROBINDO PHARMA
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.
