FDA.reportPublic FDA data

Application 077050

Type
ANDA
Sponsor
SUN PHARM INDS (IN)

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo
002ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 8MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-834ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDERebel Distributors CorpANDACurrent
21695-835ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDERebel Distributors CorpANDACurrent
35356-679ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
50436-0131ondansetron hydrochlorideondansetron hydrochlorideUnit Dose ServicesANDACurrent
55045-3729ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEDispensing Solutions, Inc.ANDACurrent
55045-3817ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEDispensing Solutions, Inc.ANDACurrent
62756-130ondansetron hydrochlorideondansetron hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-130ondansetron hydrochlorideondansetron hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-130ondansetron hydrochlorideondansetron hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-131ondansetron hydrochlorideondansetron hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-131ondansetron hydrochlorideondansetron hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-131ondansetron hydrochlorideondansetron hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
63629-4023ondansetron hydrochlorideondansetron hydrochlorideBryant Ranch PrepackANDACurrent
63629-4023ondansetron hydrochlorideondansetron hydrochlorideBryant Ranch PrepackANDACurrent
63629-4023ondansetron hydrochlorideondansetron hydrochlorideBryant Ranch PrepackANDACurrent
63629-4093ondansetron hydrochlorideondansetron hydrochlorideBryant Ranch PrepackANDACurrent
63629-4093ondansetron hydrochlorideondansetron hydrochlorideBryant Ranch PrepackANDACurrent
63629-4093ondansetron hydrochlorideondansetron hydrochlorideBryant Ranch PrepackANDACurrent
63629-6709ondansetron hydrochlorideondansetron hydrochlorideBryant Ranch PrepackANDACurrent
63629-6709ondansetron hydrochlorideondansetron hydrochlorideBryant Ranch PrepackANDACurrent
66336-793ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEDispensing Solutions, Inc.ANDACurrent