FDA.reportPublic FDA data

Application 213425

Type
ANDA
Sponsor
BE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPTOMYCINDAPTOMYCINPOWDER;IV (INFUSION)350MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69097-850daptomycindaptomycinCipla USA Inc.ANDACurrent
71839-108daptomycindaptomycinBE Pharmaceuticals Inc.ANDACurrent
71839-108daptomycindaptomycinBE Pharmaceuticals Inc.ANDACurrent
71839-108daptomycindaptomycinBE Pharmaceuticals Inc.ANDACurrent