FDA.reportPublic FDA data

Application 018890

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002METRONIDAZOLE IN PLASTIC CONTAINERMETRONIDAZOLEINJECTABLE;INJECTION500MG/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9911METRONIDAZOLEMETRONIDAZOLEHenry Schein, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811METRONIDAZOLEMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811METRONIDAZOLEMETRONIDAZOLEHospira, Inc.NDACurrent
0409-7811MetronidazoleMETRONIDAZOLEHospira, Inc.NDACurrent
52584-811METRONIDAZOLEMETRONIDAZOLEGeneral Injectables and Vaccines, Inc.NDACurrent
52584-811METRONIDAZOLEMETRONIDAZOLEGeneral Injectables and Vaccines, Inc.NDACurrent
52584-811METRONIDAZOLEMETRONIDAZOLEGeneral Injectables and Vaccines, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81618SUPPL 2025-03-18
81611SUPPL 2025-03-17
79019SUPPL 2024-07-09
79006SUPPL 2024-07-09
75695SUPPL 2023-10-10
75688SUPPL 2023-10-10
69672SUPPL2021-12-20
69607SUPPL2021-12-17
66694SUPPL2021-03-09
66669SUPPL2021-03-09
53627SUPPL2018-04-05
53606SUPPL2018-04-04
33635SUPPL2015-07-16
16081SUPPL2015-07-14