FDA.reportPublic FDA data

Application 040424

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPIRONOLACTONESPIRONOLACTONETABLET;ORAL25MGNoNo
002SPIRONOLACTONESPIRONOLACTONETABLET;ORAL50MGNoNo
003SPIRONOLACTONESPIRONOLACTONETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0243SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0243SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0243SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0243SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0243SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0437SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0437SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0437SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0437SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0437SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-2146SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-2146SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-2146SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-2146SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0378-2146SpironolactonespironolactoneMylan Pharmaceuticals Inc.ANDACurrent
0615-1535SpironolactonespironolactoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5592SpironolactonespironolactoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6591SpironolactonespironolactoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-103SpironolactonespironolactoneMylan Institutional Inc.ANDACurrent
51079-103SpironolactonespironolactoneMylan Institutional Inc.ANDACurrent
51079-103SpironolactonespironolactoneMylan Institutional Inc.ANDACurrent
51079-979SpironolactonespironolactoneMylan Institutional Inc.ANDACurrent
51079-979SpironolactonespironolactoneMylan Institutional Inc.ANDACurrent
51079-979SpironolactonespironolactoneMylan Institutional Inc.ANDACurrent
51079-980SpironolactonespironolactoneMylan Institutional Inc.ANDACurrent
51079-980SpironolactonespironolactoneMylan Institutional Inc.ANDACurrent
51079-980SpironolactonespironolactoneMylan Institutional Inc.ANDACurrent
55154-5055SpironolactonespironolactoneCardinal HealthANDACurrent
55154-5055SpironolactonespironolactoneCardinal HealthANDACurrent
55154-5517SpironolactonespironolactoneCardinal HealthANDACurrent
55154-5517SpironolactonespironolactoneCardinal HealthANDACurrent
55154-5517SpironolactonespironolactoneCardinal Health 107, LLCANDACurrent
55154-5517SpironolactonespironolactoneCardinal HealthANDACurrent
67544-310SpironolactonespironolactoneAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-310SpironolactonespironolactoneAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-310SpironolactonespironolactoneAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38896ORIG2004-06-18
22139ORIG2003-07-31
7658ORIG2003-04-10