FDA.reportPublic FDA data

Application 074190

Type
ANDA
Sponsor
HIKMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3630NaproxenNaproxenHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3630NaproxenNaproxenHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3630NaproxenNaproxenHikma Pharmaceuticals USA Inc.ANDACurrent
68134-201NaproxenNaproxenPalmetto PharmaceuticalsANDACurrent
68134-201NaproxenNaproxenPalmetto PharmaceuticalsANDACurrent
68134-201NaproxenNaproxenPalmetto PharmaceuticalsANDACurrent
68134-201NaproxenNaproxenPalmetto PharmaceuticalsANDACurrent