FDA.reportPublic FDA data

Application 210901

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

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
65162-890Olopatadine HydrochlorideOlopatadine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-890Olopatadine HydrochlorideOlopatadine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-890Olopatadine HydrochlorideOlopatadine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-890Olopatadine HydrochlorideOlopatadine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-890Olopatadine HydrochlorideOlopatadine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent