Application 204016

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLEDRONIC ACIDZOLEDRONIC ACIDSOLUTION;INTRAVENOUSEQ 4MG BASE/100ML (EQ 0.04MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-4229Zoledronic AcidZOLEDRONIC ACIDHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56950SUPPL2018-12-21
56900SUPPL2018-12-20
43451ORIG2016-06-27
40339ORIG2015-12-31
10271ORIG2015-12-30
32490ORIG2013-07-08