FDA.reportPublic FDA data

Application 208418

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CALCIUM GLUCONATECALCIUM GLUCONATESOLUTION;INTRAVENOUS1GM/10ML (100MG/ML)YesYes
002CALCIUM GLUCONATECALCIUM GLUCONATESOLUTION;INTRAVENOUS5GM/50ML (100MG/ML)YesYes
003CALCIUM GLUCONATECALCIUM GLUCONATESOLUTION;INTRAVENOUS10GM/100ML (100MG/ML)YesYes
004CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATESOLUTION;INTRAVENOUS1GM/50ML (20MG/ML)YesNo
005CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATESOLUTION;INTRAVENOUS2GM/100ML (20MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9831Calcium GluconateCalcium GluconateHenry Schein, Inc.NDACurrent
0404-9831Calcium GluconateCalcium GluconateHenry Schein, Inc.NDACurrent
50090-3398Calcium GluconateCalcium GluconateA-S Medication SolutionsNDACurrent
51662-1312CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1312CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1312CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1312CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1347CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1347CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1347CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1347CALCIUM GLUCONATECALCIUM GLUCONATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-360Calcium GluconateCalcium GluconateGeneral Injectables and Vaccines, Inc.NDACurrent
52584-360Calcium GluconateCalcium GluconateGeneral Injectables and Vaccines, Inc.NDACurrent
52584-360Calcium GluconateCalcium GluconateGeneral Injectables and Vaccines, Inc.NDACurrent
63323-360Calcium GluconateCalcium GluconateFresenius Kabi USA, LLCNDACurrent
63323-360Calcium GluconateCalcium GluconateFresenius Kabi USA, LLCNDACurrent
63323-360Calcium GluconateCalcium GluconateFresenius Kabi USA, LLCNDACurrent
65219-162Calcium GluconateCalcium GluconateFresenius Kabi USA, LLCNDACurrent
65219-164Calcium GluconateCalcium GluconateFresenius Kabi USA, LLCNDACurrent
71872-7222Calcium GluconateCalcium GluconateMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72406SUPPL2022-10-19
72404SUPPL2022-10-18
69808SUPPL2022-01-04
69801SUPPL2021-12-30
67875SUPPL2021-06-23
67863SUPPL2021-06-22
54464SUPPL2018-06-05
54230ORIG2018-05-17
48746ORIG2017-06-16
48730ORIG2017-06-16
52403ORIG1900-01-01
52402ORIG1900-01-01
52401ORIG1900-01-01