FDA.reportPublic FDA data

Application 205937

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOPENTOLATE HYDROCHLORIDECYCLOPENTOLATE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-096CyclopentolateCyclopentolate HydrochlorideAkornANDACurrent
17478-096CyclopentolateCyclopentolate HydrochlorideAkorn, Inc.ANDACurrent
17478-096CyclopentolateCyclopentolate HydrochlorideAkorn, Inc.ANDACurrent