FDA.reportPublic FDA data

Application 078510

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPLERENONEEPLERENONETABLET;ORAL25MGNoNo
002EPLERENONEEPLERENONETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-5368EplerenoneEplerenoneEon Labs, Inc.ANDACurrent
0185-5368EplerenoneEplerenoneEon Labs, Inc.ANDACurrent
0185-5368EplerenoneEplerenoneEon Labs, Inc.ANDACurrent
0185-5369EplerenoneEplerenoneEon Labs, Inc.ANDACurrent
0185-5369EplerenoneEplerenoneEon Labs, Inc.ANDACurrent
0185-5369EplerenoneEplerenoneEon Labs, Inc.ANDACurrent
0832-0480EplerenoneEplerenoneUpsher-Smith Laboratories, LLCANDACurrent
0832-0480EplerenoneEplerenoneUpsher-Smith Laboratories, LLCANDACurrent
0832-0481EplerenoneEplerenoneUpsher-Smith Laboratories, LLCANDACurrent
0832-0481EplerenoneEplerenoneUpsher-Smith Laboratories, LLCANDACurrent
42254-011EplerenoneEplerenoneRebel Distributors Corp.ANDACurrent
68084-948EplerenoneEplerenoneAmerican Health PackagingANDACurrent
68084-948EplerenoneEplerenoneAmerican Health PackagingANDACurrent