FDA.reportPublic FDA data

Application 202882

Type
ANDA
Sponsor
HETERO LABS LTD V

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
31722-712PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-712PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-712PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-712PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-712PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-713PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-713PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-713PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-713PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.ANDACurrent
31722-713PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.ANDACurrent
42708-104PANTOPRAZOLE SODIUMPANTOPRAZOLEQPharma IncANDACurrent
42708-104PANTOPRAZOLE SODIUMPANTOPRAZOLEQPharma IncANDACurrent
45865-130PANTOPRAZOLE SODIUMPANTOPRAZOLEMedsource PharmaceuticalsANDACurrent
50090-5793PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication SolutionsANDACurrent
50090-5794PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication SolutionsANDACurrent
50436-0712PANTOPRAZOLE SODIUMPANTOPRAZOLEUnit Dose ServicesANDACurrent
50436-0712PANTOPRAZOLE SODIUMPANTOPRAZOLEUnit Dose ServicesANDACurrent
55700-790PANTOPRAZOLE SODIUMPANTOPRAZOLEQuality Care Products, LLCANDACurrent
55700-790PANTOPRAZOLE SODIUMPANTOPRAZOLEQuality Care Products, LLCANDACurrent
55700-790PANTOPRAZOLE SODIUMPANTOPRAZOLEQuality Care Products, LLCANDACurrent
55700-850PANTOPRAZOLE SODIUMPANTOPRAZOLEQuality Care Products, LLCANDACurrent
55700-850PANTOPRAZOLE SODIUMPANTOPRAZOLEQuality Care Products, LLCANDACurrent
55700-850PANTOPRAZOLE SODIUMPANTOPRAZOLEQuality Care Products, LLCANDACurrent
55700-850PANTOPRAZOLE SODIUMPANTOPRAZOLEQuality Care Products, LLCANDACurrent
55700-850PANTOPRAZOLE SODIUMPANTOPRAZOLEQuality Care Products, LLCANDACurrent
55700-850PANTOPRAZOLE SODIUMPANTOPRAZOLEQuality Care Products, LLCANDACurrent
55700-850PANTOPRAZOLE SODIUMPANTOPRAZOLEQuality Care Products, LLCANDACurrent
60760-679PANTOPRAZOLE SODIUMPANTOPRAZOLESt Mary's Medical Park PharmacyANDACurrent
60760-712PANTOPRAZOLE SODIUMPANTOPRAZOLESt. Mary's Medical Park PharmacyANDACurrent
60760-712PANTOPRAZOLE SODIUMPANTOPRAZOLESt. Mary's Medical Park PharmacyANDACurrent
63187-654PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LPANDACurrent
63187-654PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LPANDACurrent
63187-654PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LPANDACurrent
63187-654PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LPANDACurrent
63187-831PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LPANDACurrent
63187-831PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LPANDACurrent
63187-831PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LPANDACurrent
68071-2215PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.ANDACurrent
68071-2215PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.ANDACurrent
68071-2215PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.ANDACurrent
68071-2285PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.ANDACurrent
68071-2285PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.ANDACurrent
68071-3038PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals, Inc.ANDACurrent
68071-4864PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4864PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.ANDACurrent
68645-596PANTOPRAZOLE SODIUMPANTOPRAZOLELegacy Pharmaceutical Packaging, LLCANDACurrent
68645-596PANTOPRAZOLE SODIUMPANTOPRAZOLELegacy Pharmaceutical Packaging, LLCANDACurrent
68788-7798PANTOPRAZOLE SODIUMPANTOPRAZOLEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7798PANTOPRAZOLE SODIUMPANTOPRAZOLEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7798PANTOPRAZOLE SODIUMPANTOPRAZOLEPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2494PANTOPRAZOLE SODIUMPANTOPRAZOLEREMEDYREPACK INC.ANDACurrent
70518-2494PANTOPRAZOLE SODIUMPANTOPRAZOLEREMEDYREPACK INC.ANDACurrent
70518-2494PANTOPRAZOLE SODIUMPANTOPRAZOLEREMEDYREPACK INC.ANDACurrent
70518-2836PANTOPRAZOLE SODIUMPANTOPRAZOLEREMEDYREPACK INC.ANDACurrent
70518-2836PANTOPRAZOLE SODIUMPANTOPRAZOLEREMEDYREPACK INC.ANDACurrent
71335-0551PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71335-0551PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71335-0551PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71335-0551PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71335-0551PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71335-0551PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71335-0551PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71335-1572PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71335-1572PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71335-1572PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71335-1572PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch PrepackANDACurrent
71610-653PANTOPRAZOLE SODIUMPANTOPRAZOLEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-659PANTOPRAZOLE SODIUMPANTOPRAZOLEAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-112PANTOPRAZOLE SODIUMpantoprazoleDIRECT RXANDACurrent
72189-112PANTOPRAZOLE SODIUMpantoprazoleDIRECT RXANDACurrent
72789-268PANTOPRAZOLE SODIUMPANTOPRAZOLEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72865-229PANTOPRAZOLE SODIUMPANTOPRAZOLEXLCare Pharmaceuticals Inc.ANDACurrent
72865-230PANTOPRAZOLE SODIUMPANTOPRAZOLEXLCare Pharmaceuticals Inc.ANDACurrent
80425-0133Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0133Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0133Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0133Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0133ProtonixPantoprazole 40mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0133ProtonixPantoprazole 40mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0162ProtonixPantoprazole 40mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent