FDA.reportPublic FDA data

Application 022581

Type
NDA
Sponsor
FRESENIUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHOSLYRACALCIUM ACETATESOLUTION;ORAL667MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49230-643Phoslyracalcium acetateFresenius Medical Care North AmericaNDACurrent
49230-643Phoslyracalcium acetateFresenius Medical Care North AmericaNDACurrent
49230-643Phoslyracalcium acetateFresenius Medical Care North AmericaNDACurrent
49230-643Phoslyracalcium acetateFresenius Medical Care North AmericaNDACurrent
49230-643Phoslyracalcium acetateFresenius Medical Care North AmericaNDACurrent
49230-643Phoslyracalcium acetateFresenius Medical Care North AmericaNDACurrent
49230-643Phoslyracalcium acetateFresenius Medical Care North AmericaNDACurrent
49230-643Phoslyracalcium acetateFresenius Medical Care North AmericaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64813SUPPL2020-10-02
64777SUPPL2020-10-01
38865SUPPL2015-05-04
29888SUPPL2015-05-04
44785ORIG2011-10-20
22067ORIG2011-10-20
17745ORIG2011-04-21
7569ORIG2011-04-20