FDA.reportPublic FDA data

Application 215042

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDECAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70954-365Phenoxybenzamine HydrochloridePhenoxybenzamine HydrochlorideNovitium Pharma LLCANDACurrent
70954-365Phenoxybenzamine HydrochloridePhenoxybenzamine HydrochlorideNovitium Pharma LLCANDACurrent