FDA.reportPublic FDA data

Application 204228

Type
ANDA
Sponsor
AJANTA PHARMA LTD

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
16714-508Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateNorthstar Rx LLCANDACurrent
16714-508Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateNorthstar Rx LLCANDACurrent
16714-508Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateNorthstar Rx LLCANDACurrent
16714-509Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateNorthstar Rx LLCANDACurrent
16714-509Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateNorthstar Rx LLCANDACurrent
16714-509Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateNorthstar Rx LLCANDACurrent
27241-031Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-031Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-031Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma USA Inc.ANDACurrent
27241-031Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-031Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma USA Inc.ANDACurrent
27241-031Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-032Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-032Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma USA Inc.ANDACurrent
27241-032Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-032Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent
27241-032Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma USA Inc.ANDACurrent
27241-032Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateAjanta Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10309ORIG2016-07-19