FDA.report

Application 091426

Type
ANDA
Sponsor
AMNEAL PHARMS

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-499SpironolactoneSpironolactoneBlenheim Pharmacal, Inc.ANDACurrent
10544-523SpironolactoneSpironolactoneBlenheim Pharmacal, Inc.ANDACurrent
42708-126SpironolactoneSpironolactoneQPharma IncANDACurrent
42708-126SpironolactoneSpironolactoneQPharma IncANDACurrent
42708-126SpironolactoneSpironolactoneQPharma IncANDACurrent
50090-1292SpironolactoneSpironolactoneA-S Medication SolutionsANDACurrent
50090-1292SpironolactoneSpironolactoneA-S Medication SolutionsANDACurrent
50090-1292SpironolactoneSpironolactoneA-S Medication SolutionsANDACurrent
50090-1308SpironolactoneSpironolactoneA-S Medication SolutionsANDACurrent
50090-1308SpironolactoneSpironolactoneA-S Medication SolutionsANDACurrent
50090-1950SpironolactoneSpironolactoneA-S Medication SolutionsANDACurrent
53002-1707SpironolactoneSpironolactoneRPK Pharmaceuticals, Inc.ANDACurrent
53746-511SpironolactoneSpironolactoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-511SpironolactoneSpironolactoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-511SpironolactoneSpironolactoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-514SpironolactoneSpironolactoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-514SpironolactoneSpironolactoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-514SpironolactoneSpironolactoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-515SpironolactoneSpironolactoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-515SpironolactoneSpironolactoneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-515SpironolactoneSpironolactoneAmneal Pharmaceuticals of New York LLCANDACurrent
53808-0979SpironolactoneSpironolactoneState of Florida DOH Central PharmacyANDACurrent
54348-340SpironolactoneSPIRONOLACTONEPharmPak, Inc.ANDACurrent
54348-340SpironolactoneSPIRONOLACTONEPharmPak, Inc.ANDACurrent
55154-1495SpironolactoneSpironolactoneCardinal Health 107, LLCANDACurrent
55154-1495SpironolactoneSpironolactoneCardinal HealthANDACurrent
55154-1495SpironolactoneSpironolactoneCardinal HealthANDACurrent
55154-1495SpironolactoneSpironolactoneCardinal HealthANDACurrent
55154-1495SpironolactoneSpironolactoneCardinal HealthANDACurrent
55154-1495SpironolactoneSpironolactoneCardinal HealthANDACurrent
55700-702SpironolactoneSpironolactoneQuality Care Products, LLANDACurrent
55700-702SpironolactoneSpironolactoneQuality Care Products, LLCANDACurrent
63739-544SpironolactoneSpironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-544SpironolactoneSpironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-544SpironolactoneSpironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-544SpironolactoneSpironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-544SpironolactoneSpironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-545SpironolactoneSpironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-545SpironolactoneSpironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-545SpironolactoneSpironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-545SpironolactoneSpironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-545SpironolactoneSpironolactoneMcKesson Corporation dba SKY PackagingANDACurrent
65162-511SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-511SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-511SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-511SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-514SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-514SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-514SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-514SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-515SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-515SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-515SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
65162-515SpironolactoneSpironolactoneAmneal Pharmaceuticals LLCANDACurrent
67046-717SpironolactoneSpironolactoneContract Pharmacy Services-PAANDACurrent
67296-1100SpironolactoneSpironolactoneRedPharm Drug, Inc.ANDACurrent
67296-1100SpironolactoneSpironolactoneRedPharm Drug, Inc.ANDACurrent
68788-7258SpironolactoneSpironolactonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7258SpironolactoneSpironolactonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7258SpironolactoneSpironolactonePreferred Pharmaceuticals Inc.ANDACurrent
68788-9729SpironolactoneSpironolactonePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0455SpironolactoneSpironolactoneREMEDYREPACK INC.ANDACurrent
70518-0455SpironolactoneSpironolactoneREMEDYREPACK INC.ANDACurrent
70518-0455SpironolactoneSpironolactoneREMEDYREPACK INC.ANDACurrent
70518-0455SpironolactoneSpironolactoneREMEDYREPACK INC.ANDACurrent
71335-0966SpironolactoneSpironolactoneBryant Ranch PrepackANDACurrent
71335-0966SpironolactoneSpironolactoneBryant Ranch PrepackANDACurrent
71335-0966SpironolactoneSpironolactoneBryant Ranch PrepackANDACurrent
71610-102SpironolactoneSpironolactoneAphena Pharma Solutions - Tennessee, LLCANDACurrent