FDA.report

Application 203253

Type
ANDA
Sponsor
JUBILANT GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SPIRONOLACTONESPIRONOLACTONETABLET;ORAL25MGNoNo
002SPIRONOLACTONESPIRONOLACTONETABLET;ORAL50MGNoNo
003SPIRONOLACTONESPIRONOLACTONETABLET;ORAL100MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
42708-101SpironolactonespironolactoneQPharma IncANDACurrent
42708-101SpironolactonespironolactoneQPharma IncANDACurrent
50090-2728SpironolactonespironolactoneA-S Medication SolutionsANDACurrent
50090-3315SpironolactonespironolactoneA-S Medication SolutionsANDACurrent
53217-240SpironolactonespironolactoneAidarex Pharmaceuticals LLCANDACurrent
55700-587SpironolactonespironolactoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
59746-216SpironolactonespironolactoneJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-217SpironolactonespironolactoneJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-218SpironolactonespironolactoneJubilant Cadista Pharmaceuticals Inc.ANDACurrent
63187-841SpironolactonespironolactoneProficient Rx LPANDACurrent
63187-841SpironolactonespironolactoneProficient Rx LPANDACurrent
63187-841SpironolactonespironolactoneProficient Rx LPANDACurrent
63187-861SpironolactonespironolactoneProficient Rx LPANDACurrent
63187-861SpironolactonespironolactoneProficient Rx LPANDACurrent
63629-2436SpironolactonespironolactoneBryant Ranch PrepackANDACurrent
63629-2436SpironolactonespironolactoneBryant Ranch PrepackANDACurrent
63629-2437SpironolactonespironolactoneBryant Ranch PrepackANDACurrent
63629-2437SpironolactonespironolactoneBryant Ranch PrepackANDACurrent
63629-2438SpironolactonespironolactoneBryant Ranch PrepackANDACurrent
63629-2438SpironolactonespironolactoneBryant Ranch PrepackANDACurrent
67296-1403SpironolactoneSpironolactoneRedPharm Drug, Inc.ANDACurrent
67296-1403SpironolactoneSpironolactoneRedPharm Drug, Inc.ANDACurrent
67296-1403SpironolactoneSpironolactoneRedPharm Drug, Inc.ANDACurrent
68071-3112SpironolactonespironolactoneNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4073SpironolactonespironolactoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6895SpironolactonespironolactonePreferred Pharmaceuticals Inc.ANDACurrent
68788-6895SpironolactonespironolactonePreferred Pharmaceuticals Inc.ANDACurrent
68788-6900SpironolactonespironolactonePreferred Pharmaceuticals Inc.ANDACurrent
68788-6900SpironolactonespironolactonePreferred Pharmaceuticals Inc.ANDACurrent
70518-0603SpironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-0603SpironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-0603SpironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-0603SpironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-0665SpironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-0665SpironolactonespironolactoneREMEDYREPACK INC.ANDACurrent