FDA.reportPublic FDA data

Application 078350

Type
ANDA
Sponsor
APOTEX

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
50090-3384Olopatadine HydrochlorideOlopatadine HydrochlorideA-S Medication SolutionsANDACurrent
51407-663Olopatadine hydrochlorideOlopatadine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60505-0575Olopatadine HydrochlorideOlopatadine HydrochlorideApotex Corp.ANDACurrent
60505-0575Olopatadine HydrochlorideOlopatadine HydrochlorideApotex Corp.ANDACurrent
60505-0575Olopatadine HydrochlorideOlopatadine HydrochlorideApotex Corp.ANDACurrent
60505-6221Olopatadine hydrochlorideOlopatadine hydrochlorideApotex Corp.ANDACurrent
68788-7301Olopatadine HydrochlorideOlopatadine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7301Olopatadine HydrochlorideOlopatadine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31359ORIG2015-12-09