FDA.reportPublic FDA data

Application 211368

Type
ANDA
Sponsor
INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-765PANTOPRAZOLE SODIUMpantoprazole sodiumAvKARE, IncANDACurrent
42291-765PANTOPRAZOLE SODIUMpantoprazole sodiumAvKAREANDACurrent
50742-151PANTOPRAZOLE SODIUMpantoprazole sodiumIngenus Pharmaceuticals, LLCANDACurrent
50742-151PANTOPRAZOLE SODIUMpantoprazole sodiumIngenus Pharmaceuticals, LLCANDACurrent
50742-151PANTOPRAZOLE SODIUMpantoprazole sodiumIngenus Pharmaceuticals, LLCANDACurrent
50742-151PANTOPRAZOLE SODIUMpantoprazole sodiumIngenus Pharmaceuticals, LLCANDACurrent
50742-151PANTOPRAZOLE SODIUMpantoprazole sodiumIngenus Pharmaceuticals, LLCANDACurrent
50742-151PANTOPRAZOLE SODIUMpantoprazole sodiumIngenus Pharmaceuticals, LLCANDACurrent