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Application 204922

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATECAPSULE;ORAL20MG;1.1GMNoNo
002OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATECAPSULE;ORAL40MG;1.1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-115Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAurolife Pharma, LLCANDACurrent
13107-115Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAurolife Pharma, LLCANDACurrent
13107-116Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAurolife Pharma, LLCANDACurrent
13107-116Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAurolife Pharma, LLCANDACurrent
69665-216Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateMedarbor LlcANDACurrent