calcium acetate Oral Solution

Brand(s)
Phoslyra
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fresenius Medical Care North America (2015-11-20)
Oldest Current Product
2011-04-15
License(s)
NDA
RxNORM
ORAL SOLUTION\CALCIUM ACETATE
FDAOB
ORAL\SOLUTION\CALCIUM ACETATE
SPL Active
ORAL\SOLUTION\CALCIUM ACETATE
SPL Moiety
ORAL\SOLUTION\CALCIUM CATION

product(s) by strength(s)

calcium acetate 133 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1492300643PhoslyraNDAFresenius Medical Care North America2011-04-15CALCIUM ACETATEORALSOLUTIONNDA022581741f71b5-5a7a-43dc-9937-066d99c50707

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA022581PHOSLYRAFRESENIUS MEDICAL CARE NORTH AMERICA2011-04-18p8591938, USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS, SUBSTANCE
p8592480, USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
p9089528, USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
NDA022581_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022581_001RXCALCIUM ACETATE (EQ 169MG CALCIUM/5ML)ORALSOLUTIONTrue2011-04-18PHOSLYRA

patent(s)

#idexpiration dateapplication(s)
1p8591938 (view patent)2030-02-23NDA022581
2p8592480 (view patent)2027-07-20NDA022581
3p9089528 (view patent)2027-07-20NDA022581

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1741f71b5-5a7a-43dc-9937-066d99c50707 (view SPL)These highlights do not include all the information needed to use PHOSLYRA safely and effectively. See full prescribing information for PHOSLYRA.PHOSLYRA (calcium acetate oral solution)Initial U.S. Approval: 1990prescriptionHuman PrescriptionFresenius Medical Care North AmericaAPI MANUFACTURE, MANUFACTURE2015-11-204492300643

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII