FDA.reportPublic FDA data

Application 091342

Type
ANDA
Sponsor
LANNETT CO INC

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
17856-0555OndansetronOndansetron HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
53002-1633OndansetronOndansetron HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1633OndansetronOndansetron HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
54838-555OndansetronOndansetron HydrochlorideLannett Company, Inc.ANDACurrent
54838-555OndansetronOndansetron HydrochlorideLannett Company, Inc.ANDACurrent
54838-555OndansetronOndansetron HydrochlorideLannett Company, Inc.ANDACurrent
54838-555OndansetronOndansetron HydrochlorideLannett Company, Inc.ANDACurrent
54838-555OndansetronOndansetron HydrochlorideLannett Company, Inc.ANDACurrent
54838-555OndansetronOndansetron HydrochlorideLannett Company, Inc.ANDACurrent
62135-555Ondansetron HydrochlorideOndansetron HydrochlorideChartwell RX, LLC.ANDACurrent
68071-2547OndansetronOndansetron HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3275OndansetronOndansetron HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4911OndansetronOndansetron HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4911OndansetronOndansetron HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
71205-109OndansetronOndansetron HydrochlorideProficient Rx LPANDACurrent
71205-109OndansetronOndansetron HydrochlorideProficient Rx LPANDACurrent
71205-109OndansetronOndansetron HydrochlorideProficient Rx LPANDACurrent
71205-109OndansetronOndansetron HydrochlorideProficient Rx LPANDACurrent