calcium acetate Oral Tablet

Brand(s)
Calphron, Eliphos
Category(s)
other, prescription
SPL Type(s)
Dietary Supplement, Human Prescription
Master SPL
Hawthorn Pharmaceutical, Inc. (2015-09-03)
Oldest Current Product
2007-04-01
License(s)
ANDA
RxNORM
ORAL TABLET\CALCIUM ACETATE
FDAOB
ORAL\TABLET\CALCIUM ACETATE
SPL Active
ORAL\TABLET\CALCIUM ACETATE
SPL Moiety
ORAL\TABLET\CALCIUM CATION

product(s) by strength(s)

calcium acetate 667 mg oral tablet

original product(s)(s)

#idbrandlabelerfirst marketedactive ingredient(s)routedose formspl
1595280331CalphronNephro-Tech, Inc.2007-04-01CALCIUM ACETATEORALTABLET86f2e3d2-dbe3-400b-91cf-a4bf41db1342

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005740113ANDAPaddock Laboratories, Llc2011-09-13CALCIUM ACETATEORALTABLETANDA09156179b7bbb6-b021-46ab-99a5-cef95472532b
2317220393ANDACamber Pharmaceuticals, Inc.2014-02-03CALCIUM ACETATEORALTABLETANDA20242049453f19-f4f4-451c-a092-3ce084f9a429
3637170910EliphosANDAHawthorn Pharmaceutical, Inc.2009-02-01CALCIUM ACETATEORALTABLETANDA0785027f58ea4d-e5cc-4898-879f-ffba6207b098
4683820642ANDAZydus Pharmaceuticals (Usa) Inc.2012-02-23CALCIUM ACETATEORALTABLETANDA202885f86caa76-047c-4be7-8c11-cba6c00a44ed

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790098EliphosANDAKaiser Foundations Hospitals2011-08-24CALCIUM ACETATEORALTABLET637170910ANDA078502139259b4-820c-4e00-84d6-dad81f00ce90
2484330300ANDASafecor Health, Llc2014-08-15CALCIUM ACETATEORALTABLET005740113ANDA091561b921a0da-4642-4b8b-ac44-7e0d278722d0
3681515204EliphosANDACarilion Materials Management2009-02-01CALCIUM ACETATEORALTABLET637170910ANDA0785029fc1ada4-9ef4-48e9-8203-32aa857d0429

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077693CALCIUM ACETATETrueROXANE LABORATORIES INC2008-01-30ANDA077693_001
2ANDA078502ELIPHOSCYPRESS PHARMACEUTICAL INC2008-11-25ANDA078502_001
3ANDA091561CALCIUM ACETATEPADDOCK LABORATORIES LLC2011-04-13ANDA091561_001
4ANDA202420CALCIUM ACETATEINVAGEN PHARMACEUTICALS INC2013-02-05ANDA202420_001
5ANDA202885CALCIUM ACETATEHERITAGE PHARMACEUTICALS INC2015-01-22ANDA202885_001
6NDA019976PHOSLOTrueFRESENIUS MEDICAL CARE NORTH AMERICA1990-12-10NDA019976_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077693_001discontinuedCALCIUM ACETATE (EQ 169MG CALCIUM)ORALTABLETFalse2008-01-30CALCIUM ACETATE
2ANDA078502_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALTABLETTrueAB2008-11-25ELIPHOS
3ANDA091561_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALTABLETFalseAB2011-04-13CALCIUM ACETATE
4ANDA202420_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALTABLETFalseAB2013-02-05CALCIUM ACETATE
5ANDA202885_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALTABLETFalseAB2015-01-22CALCIUM ACETATE
6NDA019976_001discontinuedCALCIUM ACETATE (EQ 169MG CALCIUM)ORALTABLETFalse1990-12-10PHOSLO

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1139259b4-820c-4e00-84d6-dad81f00ce90 (view SPL)prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2011-09-153001790098
249453f19-f4f4-451c-a092-3ce084f9a429 (view SPL)These highlights do not include all the information needed to use calcium acetate tablets safely and effectively. See full prescribing information for calcium acetate tablets. Calcium Acetate Tablets, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.manufacture2014-01-211317220393
379b7bbb6-b021-46ab-99a5-cef95472532b (view SPL)Calcium Acetate Tablets, USP NDC 0574-0113-02 Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2015-08-196005740113
47f58ea4d-e5cc-4898-879f-ffba6207b098 (view SPL)These highlights do not include all the information needed to use ELIPHOS Tablets safely and effectively. See full prescribing information for ELIPHOS Tablets. ELIPHOS Tablets (calcium acetate): 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionHawthorn Pharmaceutical, Inc.2015-09-032637170910
586f2e3d2-dbe3-400b-91cf-a4bf41db1342 (view SPL)Calphron (calcium acetate)otherDietary SupplementNephro-Tech, Inc.manufacture2014-07-162595280331
69fc1ada4-9ef4-48e9-8203-32aa857d0429 (view SPL)Eliphos Tablets (Calcium Acetate Tablets, USP)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-09-122681515204
7b921a0da-4642-4b8b-ac44-7e0d278722d0 (view SPL)Calcium Acetate Tablets, USPprescriptionHuman PrescriptionSafecor Health, LlcRELABEL, REPACK, STERILIZE2011-09-142484330300
8f86caa76-047c-4be7-8c11-cba6c00a44ed (view SPL)Rx Only These highlights do not include all the information needed to use Calcium Acetate Tablets safely and effectively. See full prescribing information for Calcium Acetate Tablets. Calcium Acetate Tablets USP for ORAL use.Initial U.S. Approval: 1990prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.analysis, label, manufacture, pack2015-01-314683820642

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