FDA.reportPublic FDA data

Application 203711

Type
ANDA
Sponsor
QILU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9930ONDANSETRONONDANSETRONHenry Schein, Inc.ANDACurrent
0404-9930ONDANSETRONONDANSETRONHenry Schein, Inc.ANDACurrent
0404-9930ONDANSETRONONDANSETRONHenry Schein, Inc.ANDACurrent
50090-4935ONDANSETRONONDANSETRONA-S Medication SolutionsANDACurrent
50090-4935ONDANSETRONONDANSETRONA-S Medication SolutionsANDACurrent
52584-069ONDANSETRONONDANSETRONGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-069ONDANSETRONONDANSETRONGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-069ONDANSETRONONDANSETRONGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-069ONDANSETRONONDANSETRONGeneral Injectables and Vaccines, Inc.ANDACurrent
60505-6130ONDANSETRONONDANSETRONApotex Corp.ANDACurrent
60505-6130ONDANSETRONONDANSETRONApotex Corp.ANDACurrent
60505-6130ONDANSETRONONDANSETRONApotex Corp.ANDACurrent
60505-6130ONDANSETRONONDANSETRONApotex Corp.ANDACurrent
60505-6130ONDANSETRONONDANSETRONApotex Corp.ANDACurrent
60505-6130ONDANSETRONONDANSETRONApotex Corp.ANDACurrent
60505-6130ONDANSETRONONDANSETRONApotex Corp.ANDACurrent
67184-0507ONDANSETRONONDANSETRONQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0507ONDANSETRONONDANSETRONQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0507ONDANSETRONONDANSETRONQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0507ONDANSETRONONDANSETRONQilu Pharmaceutical Co., Ltd.ANDACurrent
70518-2650ONDANSETRONONDANSETRONREMEDYREPACK INC.ANDACurrent
70518-2650ONDANSETRONONDANSETRONREMEDYREPACK INC.ANDACurrent
70518-2650ONDANSETRONONDANSETRONREMEDYREPACK INC.ANDACurrent
71872-7068ONDANSETRONONDANSETRONMedical Purchasing Solutions, LLCANDACurrent
71872-7068ONDANSETRONONDANSETRONMedical Purchasing Solutions, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40323ORIG2014-09-23
32462ORIG2014-09-10