FDA.reportPublic FDA data

Application 078776

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDESOLUTION;ORALEQ 4MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-671OndansetronOndansetron HydrochlorideNorthStar Rx LLCANDACurrent
16714-671OndansetronOndansetron HydrochlorideNorthStar Rx LLCANDACurrent
16714-671OndansetronOndansetron HydrochlorideNorthStar Rx LLCANDACurrent
16714-671OndansetronOndansetron HydrochlorideNorthStar Rx LLCANDACurrent
16714-671OndansetronOndansetron HydrochlorideNorthStar Rx LLCANDACurrent
65862-208OndansetronOndansetron HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-208OndansetronOndansetron HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-208OndansetronOndansetron HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-208OndansetronOndansetron HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-208OndansetronOndansetron HydrochlorideAurobindo Pharma LimitedANDACurrent