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Application 077619

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASENoNo
002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53808-1007PantoprazolePantoprazoleState of Florida DOH Central PharmacyANDACurrent
53808-1081PantoprazolePantoprazoleState of Florida DOH Central PharmacyANDACurrent
55111-332PantoprazolePantoprazoleDr.Reddy's Laboratories LimitedANDACurrent
55111-332PantoprazolePantoprazoleDr.Reddy's Laboratories LimitedANDACurrent
55111-332PantoprazolePantoprazoleDr.Reddy's Laboratories LimitedANDACurrent
55111-333PantoprazolePantoprazoleDr.Reddy's Laboratories LimitedANDACurrent
55111-333PantoprazolePantoprazoleDr.Reddy's Laboratories LimitedANDACurrent
55111-333PantoprazolePantoprazoleDr.Reddy's Laboratories LimitedANDACurrent
60760-574PantoprazolePantoprazoleST. MARY'S MEDICAL PARK PHARMACYANDACurrent
68071-2845PantoprazolePantoprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2891PantoprazolePantoprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2891PantoprazolePantoprazoleNuCare Pharmaceuticals,Inc.ANDACurrent