FDA.reportPublic FDA data

Application 091483

Type
ANDA
Sponsor
AMNEAL PHARMS

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
0904-7073OndansetronOndansetronMajor PharmaceuticalsANDACurrent
0904-7073OndansetronOndansetronMajor PharmaceuticalsANDACurrent
0904-7073OndansetronOndansetronMajor PharmaceuticalsANDACurrent
17856-0691OndansetronOndansetronAtlantic Biologicals CorpsANDACurrent
17856-0691OndansetronOndansetronATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0691OndansetronOndansetronAtlantic Biologicals CorpsANDACurrent
17856-0691OndansetronOndansetronATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-4091OndansetronOndansetronAtlantic Biologicals CorpsANDACurrent
60687-252OndansetronOndansetronAmerican Health PackagingANDACurrent
60687-252OndansetronOndansetronAmerican Health PackagingANDACurrent
60687-252OndansetronOndansetronAmerican Health PackagingANDACurrent
60687-252OndansetronOndansetronAmerican Health PackagingANDACurrent
65162-691OndansetronOndansetronAmneal Pharmaceuticals LLCANDACurrent
65162-691OndansetronOndansetronAmneal Pharmaceuticals LLCANDACurrent
65162-691OndansetronOndansetronAmneal Pharmaceuticals of New York, LLCANDACurrent
65162-691OndansetronOndansetronAmneal Pharmaceuticals LLCANDACurrent
65162-691OndansetronOndansetronAmneal Pharmaceuticals LLCANDACurrent
70166-486OndansetronOndansetronLohxaANDACurrent
70166-486OndansetronOndansetronLohxaANDACurrent