FDA.reportPublic FDA data

Application 206087

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.2% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69097-276Olopatadine HydrochlorideOlopatadine Hydrochloride Ophthalmic SolutionCipla USA Inc.ANDACurrent
69097-600Olopatadine HydrochlorideOlopatadine HydrochlorideCipla USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48976ORIG2017-07-13