FDA.reportPublic FDA data

Application 202600

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEONDANSETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3839OndansetronOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-3839OndansetronOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
55150-125OndansetronOndansetron HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-125OndansetronOndansetron HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-125OndansetronOndansetron HydrochlorideAuroMedics Pharma LLCANDACurrent
55154-8329OndansetronOndansetron HydrochlorideCardinal HealthANDACurrent