FDA.reportPublic FDA data

Application 205274

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLINAMOXICILLINTABLET, CHEWABLE;ORAL125MGNoNo
002AMOXICILLINAMOXICILLINTABLET, CHEWABLE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9820AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9821AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent