FDA.reportPublic FDA data

Application 021160

Type
NDA
Sponsor
FRESENIUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHOSLOCALCIUM ACETATECAPSULE;ORAL333.5MGNoNo
002PHOSLOCALCIUM ACETATECAPSULE;ORAL667MGNoNo
003PHOSLO GELCAPSCALCIUM ACETATECAPSULE;ORAL667MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-2081Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2081Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2081Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2081Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2081Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2081Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2672Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2672Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2672Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2672Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2672Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2672Calcium AcetateCalcium AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
49230-640PhosLoCalcium AcetateFresenius Medical Care North AmericaNDACurrent
49230-640PhosLoCalcium AcetateFresenius Medical Care North AmericaNDACurrent
49230-640PhosLoCalcium AcetateFresenius Medical Care North AmericaNDACurrent
49230-640PhosLoCalcium AcetateFresenius Medical Care North AmericaNDACurrent
49230-640PhosLoCalcium AcetateFresenius Medical Care North AmericaNDACurrent
49230-644Calcium AcetateCalcium AcetateFresenius Medical Care North AmericaNDA AUTHORIZED GENERICCurrent
49230-644Calcium AcetateCalcium AcetateFresenius Medical Care North AmericaNDA AUTHORIZED GENERICCurrent
49230-644Calcium AcetateCalcium AcetateFresenius Medical Care North AmericaNDA AUTHORIZED GENERICCurrent
49230-644Calcium AcetateCalcium AcetateFresenius Medical Care North AmericaNDA AUTHORIZED GENERICCurrent
53808-0905Calcium AcetateCalcium AcetateState of Florida DOH Central PharmacyNDA AUTHORIZED GENERICCurrent
70518-2372Calcium AcetateCalcium AcetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2372Calcium AcetateCalcium AcetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2372Calcium AcetateCalcium AcetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2372Calcium AcetateCalcium AcetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2372Calcium AcetateCalcium AcetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71335-1351Calcium AcetateCalcium AcetateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1351Calcium AcetateCalcium AcetateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47810SUPPL2017-03-30
4506SUPPL2011-03-31
26939SUPPL2004-03-02
41995ORIG2001-04-02
36244ORIG2001-04-02
4505ORIG2001-04-02