FDA.reportPublic FDA data

Application 207322

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-596Polymyxin Bpolymyxin B sulfateAlvogen Inc.ANDACurrent
47781-596Polymyxin Bpolymyxin B sulfateAlvogen Inc.ANDACurrent
51991-939Polymyxin BPolymyxin BBreckenridge PharmaceuticANDACurrent
68083-174POLYMYXIN BPOLYMYXIN B SULFATEGland Pharma LimitedANDACurrent
68083-174POLYMYXIN BPOLYMYXIN B SULFATEGland Pharma LimitedANDACurrent
68083-174POLYMYXIN BPOLYMYXIN B SULFATEGland Pharma LimitedANDACurrent
70860-103Polymyxin Bpolymyxin B sulfateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-103Polymyxin Bpolymyxin B sulfateAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-124Polymyxin Bpolymyxin B sulfateAthenex Pharmaceutical Division, LLC.ANDACurrent