FDA.reportPublic FDA data

Application 084300

Type
ANDA
Sponsor
ALCON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOMYDRILCYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.2%;1%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0359Cyclomydrilcyclopentolate hydrochloride and phenylephrine hydrochlorideAlcon Laboratories, Inc.ANDACurrent
0065-0359Cyclomydrilcyclopentolate hydrochloride and phenylephrine hydrochlorideAlcon Laboratories, Inc.ANDACurrent
0065-0359Cyclomydrilcyclopentolate hydrochloride and phenylephrine hydrochlorideAlcon Laboratories, Inc.ANDACurrent
0065-0359Cyclomydrilcyclopentolate hydrochloride and phenylephrine hydrochlorideAlcon Laboratories, Inc.ANDACurrent
0065-0359Cyclomydrilcyclopentolate hydrochloride and phenylephrine hydrochlorideAlcon Laboratories, Inc.ANDACurrent