FDA.reportPublic FDA data

Application 208803

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZETIMIBEEZETIMIBETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3087EzetimibeEzetimibeA-S Medication SolutionsANDACurrent
50268-298EzetimibeEzetimibeAvPAKANDACurrent
50268-298EzetimibeEzetimibeAvPAKANDACurrent
69238-1154EzetimibeEzetimibeAmneal Pharmaceuticals NY LLCANDACurrent
69238-1154EzetimibeEzetimibeAmneal Pharmaceuticals NY LLCANDACurrent
69238-1154EzetimibeEzetimibeAmneal Pharmaceuticals LLCANDACurrent
69238-1154EzetimibeEzetimibeAmneal Pharmaceuticals LLANDACurrent
69238-1154EzetimibeEzetimibeAmneal Pharmaceuticals NY LLCANDACurrent
71335-0684EzetimibeEzetimibeBryant Ranch PrepackANDACurrent