Orange Book product · Generic (ANDA)
OMEPRAZOLE AND SODIUM BICARBONATE
OMEPRAZOLE; SODIUM BICARBONATE
At a glance
Jul 27, 2016
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 27, 2016
10 yr ago
Today
Pharmaceutical detail
Active ingredient
OMEPRAZOLE; SODIUM BICARBONATE
Strength
40MG/PACKET;1.68GM/PACKET
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 205545
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of OMEPRAZOLE; SODIUM BICARBONATE
- 2022KONVOMEPBrand (NDA)
NDA 213593 · AZURITY
- 2013ZEGERID OTCBrand (NDA)
NDA 022283 · RILEY CONSUMER
- 2009ZEGERID OTCBrand (NDA)
NDA 022281 · RILEY CONSUMER
- 2006ZEGERIDBrand (NDA)
NDA 021849 · SALIX
- 2004ZEGERIDBrand (NDA)
NDA 021636 · SALIX
- 2025OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 219161 · NOVITIUM PHARMA
- 2024OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 217784 · DR REDDYS
- 2020OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 212587 · ANDA REPOSITORY
- 2018OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 203290 · ZYDUS PHARMS
- 2018OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 203345 · ZYDUS
- 2016OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 207476 · SCIEGEN PHARMS
- 2016OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 204923 · 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.
