FDA.reportPublic FDA data

Application 040164

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AKPENTOLATECYCLOPENTOLATE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-100Cyclopentolate HydrochlorideCyclopentolate HydrochlorideAkornANDACurrent
17478-100Cyclopentolate HydrochlorideCyclopentolate HydrochlorideAkornANDACurrent
17478-100Cyclopentolate HydrochlorideCyclopentolate HydrochlorideAkorn, Inc.ANDACurrent
17478-100Cyclopentolate HydrochlorideCyclopentolate HydrochlorideAkornANDACurrent
17478-100Cyclopentolate HydrochlorideCyclopentolate HydrochlorideAkorn, Inc.ANDACurrent
17478-100Cyclopentolate HydrochlorideCyclopentolate HydrochlorideAkornANDACurrent
21695-883AK-PENTOLATECyclopentolate HydrochlorideRebel Distributors Corp.ANDACurrent
50090-3874Cyclopentolate HydrochlorideCyclopentolate HydrochlorideA-S Medication SolutionsANDACurrent
50090-3874Cyclopentolate HydrochlorideCyclopentolate HydrochlorideA-S Medication SolutionsANDACurrent