FDA.reportPublic FDA data

Application 204392

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.1% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-8023Olopatadine HydrochlorideOlopatadine HydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-8023Olopatadine HydrochlorideOlopatadine HydrochlorideMylan Pharmaceuticals Inc.ANDACurrent