FDA.reportPublic FDA data

Application 213757

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESPRAY, METERED;NASAL0.665MG/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-943Olopatadine HydrochlorideOlopatadine Hydrochloride NasalHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-943Olopatadine HydrochlorideOlopatadine Hydrochloride NasalHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-943Olopatadine HydrochlorideOlopatadine Hydrochloride NasalAkornANDACurrent
50383-943Olopatadine HydrochlorideOlopatadine Hydrochloride NasalAkornANDACurrent
50383-943Olopatadine HydrochlorideOlopatadine Hydrochloride NasalHi-Tech Pharmacal Co., Inc.ANDACurrent