FDA.reportPublic FDA data

Application 204055

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPINASTINE HYDROCHLORIDEEPINASTINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.05%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-911EpinastineEpinastine HydrochlorideAkorn, Inc.ANDACurrent
17478-911EpinastineEpinastine HydrochlorideAkorn, Inc.ANDACurrent
17478-911EpinastineEpinastine HydrochlorideAkornANDACurrent