Application 206589

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
55150-234Polymyxin BPolymyxin BAuroMedics Pharma LLCANDACurrent
55150-234Polymyxin BPolymyxin BAuroMedics Pharma LLCANDACurrent
55150-234Polymyxin BPolymyxin BAuroMedics Pharma LLCANDACurrent