FDA.reportPublic FDA data

Application 090970

Type
ANDA
Sponsor
MYLAN PHARMS INC

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
0378-6688Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6688Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6688Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6688Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6688Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6688Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6689Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6689Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6689Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6689Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6689Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6689Pantoprazole Sodiumpantoprazole sodiumMylan Pharmaceuticals Inc.ANDACurrent
0615-7629Pantoprazole Sodiumpantoprazole sodiumNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7629Pantoprazole Sodiumpantoprazole sodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-051Pantoprazole Sodiumpantoprazole sodiumMylan Institutional Inc.ANDACurrent
51079-051Pantoprazole Sodiumpantoprazole sodiumMylan Institutional Inc.ANDACurrent
51079-051Pantoprazole Sodiumpantoprazole sodiumMylan Institutional Inc.ANDACurrent
51079-051Pantoprazole Sodiumpantoprazole sodiumMylan Institutional Inc.ANDACurrent
51079-051Pantoprazole Sodiumpantoprazole sodiumMylan Institutional Inc.ANDACurrent
51079-051Pantoprazole Sodiumpantoprazole sodiumMylan Institutional Inc.ANDACurrent
51655-500Pantoprazole Sodium Delayed ReleasePantoprazole Sodium Delayed ReleaseNorthwind PharmaceuticalsANDACurrent
55154-4382Pantoprazole Sodiumpantoprazole sodiumCardinal HealthANDACurrent
55154-4382Pantoprazole Sodiumpantoprazole sodiumCardinal HealthANDACurrent
55154-4382Pantoprazole Sodiumpantoprazole sodiumCardinal HealthANDACurrent
55154-4382Pantoprazole Sodiumpantoprazole sodiumCardinal HealthANDACurrent
55154-4382Pantoprazole Sodiumpantoprazole sodiumCardinal HealthANDACurrent
55154-4382Pantoprazole Sodiumpantoprazole sodiumCardinal HealthANDACurrent
55700-019Pantoprazole Sodiumpantoprazole sodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-019Pantoprazole Sodiumpantoprazole sodiumLake Erie Medical DBA QuaANDACurrent
55700-318Pantoprazole Sodiumpantoprazole sodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-318Pantoprazole Sodiumpantoprazole sodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-318Pantoprazole Sodiumpantoprazole sodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-318Pantoprazole Sodiumpantoprazole sodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-318Pantoprazole Sodiumpantoprazole sodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
70518-1264Pantoprazole Sodiumpantoprazole sodiumREMEDYREPACK INC.ANDACurrent
70518-1264Pantoprazole Sodiumpantoprazole sodiumREMEDYREPACK INC.ANDACurrent
71335-1429Pantoprazole Sodiumpantoprazole sodiumBryant Ranch PrepackANDACurrent
71335-1429Pantoprazole Sodiumpantoprazole sodiumBryant Ranch PrepackANDACurrent
71335-1429Pantoprazole Sodiumpantoprazole sodiumBryant Ranch PrepackANDACurrent
71335-1667Pantoprazole Sodiumpantoprazole sodiumBryant Ranch PrepackANDACurrent
71335-1667Pantoprazole Sodiumpantoprazole sodiumBryant Ranch PrepackANDACurrent
71335-1667Pantoprazole Sodiumpantoprazole sodiumBryant Ranch PrepackANDACurrent
71335-1667Pantoprazole Sodiumpantoprazole sodiumBryant Ranch PrepackANDACurrent
80425-0179Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0179Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0179Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent