FDA.reportPublic FDA data

Application 203231

Type
NDA
Sponsor
INFORLIFE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLEDRONIC ACIDZOLEDRONIC ACIDINJECTABLE;INTRAVENOUSEQ 4MG BASE/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-826zoledronic acidzoledronic acidSagent PharmaceuticalsNDACurrent
25021-826zoledronic acidzoledronic acidSagent PharmaceuticalsNDACurrent
25021-826zoledronic acidzoledronic acidSagent PharmaceuticalsNDACurrent
25021-826zoledronic acidzoledronic acidSagent PharmaceuticalsNDACurrent
25021-826zoledronic acidzoledronic acidSagent PharmaceuticalsNDACurrent
25021-826zoledronic acidzoledronic acidSagent PharmaceuticalsNDACurrent
25021-826zoledronic acidzoledronic acidSagent PharmaceuticalsNDACurrent
25021-826zoledronic acidzoledronic acidSagent PharmaceuticalsNDACurrent
25021-826zoledronic acidzoledronic acidSagent PharmaceuticalsNDACurrent
25021-826zoledronic acidzoledronic acidSagent PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70707SUPPL2022-04-06
70705SUPPL2022-04-06
65112SUPPL2020-10-30
65111SUPPL2020-10-30
65110SUPPL2020-10-30
65070SUPPL2020-10-29
65069SUPPL2020-10-29
47094SUPPL2017-02-03
47093SUPPL2017-02-03
19451SUPPL2016-03-29
10192SUPPL2016-03-29
40281SUPPL2015-10-15
32400SUPPL2015-10-13
32399SUPPL2014-12-12
32398SUPPL2014-12-12
10191SUPPL2014-12-12
40280SUPPL2014-12-11
40279SUPPL2014-12-11
19450SUPPL2014-12-11
40278SUPPL2014-05-06
32397SUPPL2014-05-06
22917ORIG2014-04-17
19449ORIG2013-08-06
10190ORIG2013-08-05
32396ORIG2012-11-13