Orange Book product · Generic (ANDA)
OMEPRAZOLE
OMEPRAZOLE
At a glance
Dec 10, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 10, 2020
5 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
OMEPRAZOLE
Strength
10MG
Dosage form
CAPSULE, DELAYED REL PELLETS
Route
ORAL
TE code
AB
Application
ANDA 212977
Product number
001
Marketing status
RX
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
- 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.
