FDA.reportPublic FDA data

Application 215041

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIFABUTINRIFABUTINCAPSULE;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-738RifabutinRifabutinMarlex Pharmaceuticals, Inc.ANDACurrent
70954-041RifabutinRifabutinNovitium Pharma LLCANDACurrent