FDA.reportPublic FDA data

Application 040353

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-2672SpironolactoneSpironolactoneActavis Pharma, Inc.ANDACurrent
0228-2673SpironolactoneSpironolactoneActavis Pharma, Inc.ANDACurrent
0228-2803SpironolactoneSpironolactoneActavis Pharma, Inc.ANDACurrent
0228-2803SpironolactoneSpironolactoneActavis Pharma, Inc.ANDACurrent
0904-5951SpironolactoneSpironolactoneMajor PharmaceuticalsANDACurrent
42254-183SpironolactoneSpironolactoneRebel Distributors CorpANDACurrent
49999-811SpironolactoneSpironolactoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
50268-726SpironolactoneSpironolactoneAvPAKANDACurrent
51655-838SPIRONOLACTONESPIRONOLACTONENorthwind Pharmaceuticals, LLCANDACurrent
53808-0796SpironolactoneSPIRONOLACTONEState of Florida DOH Central PharmacyANDACurrent
68151-2776SpironolactoneSpironolactoneCarilion Materials ManagementANDACurrent
68788-9124SpironolactonespironolactonePreferred Pharmaceuticals, IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7634ORIG1999-07-29