FDA.reportPublic FDA data

Application 202766

Type
ANDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLYMYXIN B SULFATEPOLYMYXIN B SULFATEINJECTABLE;INJECTIONEQ 500,000 UNITS BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-0170Polymyxin BPolymyxin BX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0171Polymyxin BPolymyxin BX-GEN Pharmaceuticals, Inc.ANDACurrent
45932-0030POLYMYXIN BPOLYMYXIN B SULFATEXellia Pharmaceuticals ApSANDACurrent
63323-367POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLCANDACurrent
63323-367Polymyxin BPolymyxin B SulfateFresenius Kabi USA, LLCANDACurrent
63323-367POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLCANDACurrent
63323-367POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLCANDACurrent
63323-367Polymyxin BPolymyxin B SulfateFresenius Kabi USA, LLCANDACurrent
70594-049Polymyxin BPolymyxin B SulfateXellia Pharmaceuticals USA LLCANDACurrent
70594-049Polymyxin BPolymyxin B SulfateXellia Pharmaceuticals USA LLCANDACurrent
70594-049Polymyxin BPolymyxin B SulfateXellia Pharmaceuticals USA LLCANDACurrent