FDA.reportPublic FDA data

Application 079182

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATEFOR SUSPENSION;ORAL20MG/PACKET;1.68GM/PACKETNoNo
002OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATEFOR SUSPENSION;ORAL40MG/PACKET;1.68GM/PACKETNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-268Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonatePar Pharmaceutical, Inc.ANDACurrent
49884-268Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonatePar Pharmaceutical, Inc.ANDACurrent
49884-268Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonatePar Pharmaceutical, Inc.ANDACurrent
49884-268Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonatePar Pharmaceutical, Inc.ANDACurrent
49884-269Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonatePar Pharmaceutical, Inc.ANDACurrent
49884-269Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonatePar Pharmaceutical, Inc.ANDACurrent
49884-269Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonatePar Pharmaceutical, Inc.ANDACurrent
49884-269Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonatePar Pharmaceutical, Inc.ANDACurrent
63629-2242Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonateBryant Ranch PrepackANDACurrent
63629-2242Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonateBryant Ranch PrepackANDACurrent
63629-2243Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonateBryant Ranch PrepackANDACurrent
63629-2243Omeprazole/Sodium BicarbonateOmeprazole and Sodium BicarbonateBryant Ranch PrepackANDACurrent
64380-182Omeprazole/Sodium BicarbonateomeprazoleStrides Pharma Science LimitedANDACurrent
64380-183Omeprazole/Sodium BicarbonateomeprazoleStrides Pharma Science LimitedANDACurrent