FDA.reportPublic FDA data

Application 019264

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENTAMPENTAMIDINE ISETHIONATEINJECTABLE;INJECTION300MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-113Pentam 300PENTAMIDINE ISETHIONATEAPP Pharmaceuticals, LLCNDACurrent
63323-113Pentam 300PENTAMIDINE ISETHIONATEFresenius Kabi USA, LLCNDACurrent
63323-113Pentam 300PENTAMIDINE ISETHIONATEFresenius Kabi USA, LLCNDACurrent