FDA.reportPublic FDA data

Application 211910

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXENNAPROXENSUSPENSION;ORAL25MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70954-151Naproxen Oral SuspensionNaproxen oralNovitium Pharma LLCANDACurrent
70954-151Naproxen Oral SuspensionNaproxen oralNovitium Pharma LLCANDACurrent