FDA.reportPublic FDA data

Application 212513

Type
ANDA
Sponsor
BE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPTOMYCINDAPTOMYCINPOWDER;INTRAVENOUS500MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3295daptomycindaptomycinSandoz Inc.ANDACurrent
0781-3295daptomycindaptomycinSandoz Inc.ANDACurrent
0781-3295daptomycindaptomycinSandoz Inc.ANDACurrent
31722-102DaptomycinDaptomycinCamber Pharmaceuticals Inc.ANDACurrent
31722-102DaptomycinDaptomycinCamber Pharmaceuticals Inc.ANDACurrent
69097-807DaptomycinDaptomycinCipla USA Inc.ANDACurrent
69097-807DaptomycinDaptomycinCipla USA Inc.ANDACurrent
69097-807DaptomycinDaptomycinCipla USA Inc.ANDACurrent
69097-807DaptomycinDaptomycinCipla USA Inc.ANDACurrent
71288-018DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.ANDACurrent
71288-018DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.ANDACurrent
71288-018DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.ANDACurrent
71288-018DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.ANDACurrent
71839-107daptomycindaptomycinBE Pharmaceuticals Inc.ANDACurrent
71839-107daptomycindaptomycinBE Pharmaceuticals Inc.ANDACurrent
71839-107daptomycindaptomycinBE Pharmaceuticals Inc.ANDACurrent
71839-107daptomycindaptomycinBE Pharmaceuticals Inc.ANDACurrent
71839-107daptomycindaptomycinBE Pharmaceuticals Inc.ANDACurrent