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Application 205545

Type
ANDA
Sponsor
AJANTA PHARMA LTD

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
27241-029Omeprazole/Sodium BicarbonateOmeprazole/Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-029Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma USA Inc.ANDACurrent
27241-029Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma USA Inc.ANDACurrent
27241-029Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-029Omeprazole/Sodium BicarbonateOmeprazole/Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-029Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-030Omeprazole/Sodium BicarbonateOmeprazole/Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-030Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma USA Inc.ANDACurrent
27241-030Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma USA Inc.ANDACurrent
27241-030Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-030Omeprazole/Sodium BicarbonateOmeprazole/Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-030Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent