FDA.report

Application 077056

Type
ANDA
Sponsor
TEVA

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0011Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0011Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0011Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0012Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0012Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0012Pantoprazole SodiumPantoprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7916Pantoprazole SodiumPantoprazole SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7998Pantoprazole SodiumPantoprazole SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7998Pantoprazole SodiumPantoprazole SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-771Pantoprazole SodiumPantoprazole SodiumRebel Distributors CorpANDACurrent
33358-536Pantoprazole SodiumPantoprazole SodiumRxChange Co.ANDACurrent
42291-658Pantoprazole SodiumPantoprazole SodiumAvKARE, Inc.ANDACurrent
42291-658Pantoprazole SodiumPantoprazole SodiumAvKARE, Inc.ANDACurrent
42291-659Pantoprazole SodiumPantoprazole SodiumAvKARE, Inc.ANDACurrent
42291-659Pantoprazole SodiumPantoprazole SodiumAvKARE, Inc.ANDACurrent
42708-069Pantoprazole SodiumPantoprazole SodiumQPharma IncANDACurrent
42708-069Pantoprazole SodiumPantoprazole SodiumQPharma IncANDACurrent
43353-343Pantoprazole SodiumPantoprazole SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-622Pantoprazole SodiumPantoprazole SodiumMedsource PharmaceuticalsANDACurrent
45865-622Pantoprazole SodiumPantoprazole SodiumMedsource PharmaceuticalsANDACurrent
50090-1415Pantoprazole SodiumPantoprazole SodiumA-S Medication SolutionsANDACurrent
50090-1415Pantoprazole SodiumPantoprazole SodiumA-S Medication SolutionsANDACurrent
50090-3095Pantoprazole SodiumPantoprazole SodiumA-S Medication SolutionsANDACurrent
51655-501Pantoprazole SodiumPantoprazole SodiumNorthwind Pharmaceuticals, LLCANDACurrent
55700-314Pantoprazole SodiumPantoprazole SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-134PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDIRECT RXANDACurrent
61919-134PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDIRECT RXANDACurrent
61919-134PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDIRECT RXANDACurrent
61919-599PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDIRECT RXANDACurrent
61919-599PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMDIRECT RXANDACurrent
63187-119Pantoprazole SodiumPantoprazole SodiumProficient Rx LPANDACurrent
63187-551Pantoprazole SodiumPantoprazole SodiumProficient Rx LPANDACurrent
63629-3353Pantoprazole SodiumPantoprazole SodiumBryant Ranch PrepackANDACurrent
63629-6533Pantoprazole SodiumPantoprazole SodiumBryant Ranch PrepackANDACurrent
67046-534Pantoprazole SodiumPantoprazole SodiumContract Pharmacy Services-PAANDACurrent
68071-2082Pantoprazole SodiumPantoprazole SodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2195Pantoprazole SodiumPantoprazole SodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4347Pantoprazole SodiumPantoprazole SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4483Pantoprazole SodiumPantoprazole SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4483Pantoprazole SodiumPantoprazole SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9254Pantoprazole SodiumPantoprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9263Pantoprazole SodiumPantoprazole SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0395Pantoprazole SodiumPantoprazole SodiumREMEDYREPACK INC.ANDACurrent
71610-103Pantoprazole SodiumPantoprazole SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-341Pantoprazole SodiumPantoprazole SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.DateStorage
89980ORIG12006-04-25Cached in FDA.report object storage