FDA.reportPublic FDA data

Application 078599

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMFIBROZILGEMFIBROZILTABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9707GemfibrozilGemfibrozilWest-ward Pharmaceutical CorpANDACurrent
59115-094GemfibrozilGemfibrozilHikma PharmaceuticalANDACurrent
59115-094GemfibrozilGemfibrozilHikma PharmaceuticalANDACurrent