FDA.reportPublic FDA data

Application 203152

Type
ANDA
Sponsor
USV

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
51293-838olopatadine hydrochlorideolopatadine hydrochlorideECI Pharmaceuticals, LLCANDACurrent
51293-838olopatadine hydrochlorideolopatadine hydrochlorideECI Pharmaceuticals, LLCANDACurrent
64980-517Olopatadine HydrochlorideOlopatadine Hydrochloride USP, 0.1%Rising Pharmaceuticals, Inc.ANDACurrent
68788-7843Olopatadine HydrochlorideOlopatadine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
69367-233Olopatadine HydrochlorideOlopatadine HydrochlorideWestminster PharmaceuticalsANDACurrent
69367-233Olopatadine HydrochlorideOlopatadine HydrochlorideWestminster Pharmaceuticals, LLCANDACurrent
70512-520Olopatadine HclOlopatadine HclSola PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19434ORIG2015-12-11
10170ORIG2015-12-09
10171ORIG2015-10-29