Orange Book product · Generic (ANDA)
OMEPRAZOLE
OMEPRAZOLE
At a glance
Oct 12, 2018
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 12, 2018
7 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
OMEPRAZOLE
Strength
20MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 207891
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OMEPRAZOLE
- 2017OMEPRAZOLEBrand (NDA)
NDA 209400 · DEXCEL
- 2007OMEPRAZOLEBrand (NDA)
NDA 022032 · DEXCEL PHARMA
- 1995PRILOSECBrand (NDA)
NDA 019810 · ASTRAZENECA
- 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 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.
