FDA.reportPublic FDA data

Application 210906

Type
NDA
Sponsor
HQ SPCLT PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-620Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-621Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-622Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-622Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent
44567-622Calcium GluconateCalcium GluconateWG Critical Care, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65121SUPPL2020-11-02
65074SUPPL2020-10-29
56751ORIG2018-12-17
56214ORIG2018-10-31
56203ORIG2018-10-31