calcium acetate Oral Capsule

Brand(s)
Phoslo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fresenius Medical Care North America (2014-08-04)
Oldest Current Product
1997-08-27
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\CALCIUM ACETATE
FDAOB
ORAL\CAPSULE\CALCIUM ACETATE
SPL Active
ORAL\CAPSULE\CALCIUM ACETATE
SPL Moiety
ORAL\CAPSULE\CALCIUM
ORAL\CAPSULE\CALCIUM CATION

product(s) by strength(s)

calcium acetate 667 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1492300640PhosloNDAFresenius Medical Care North America2001-04-02CALCIUM ACETATEORALCAPSULENDA02116034a29fae-b549-41ed-bd7d-e98fe2110bef

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540088ANDARoxane Laboratories, Inc2008-02-26CALCIUM ACETATEORALCAPSULEANDA07772885fd41f8-2823-44ca-a15e-f1f2e5d0ff94
2007812081NDA AUTHORIZED GENERICSandoz Inc2012-03-14CALCIUM ACETATEORALCAPSULENDA0211604d5c8c68-2755-4d7c-b689-6c5e50ff1b26
3007812672NDA AUTHORIZED GENERICSandoz Inc2012-03-14CALCIUM ACETATEORALCAPSULENDA0211604d5c8c68-2755-4d7c-b689-6c5e50ff1b26
4231550531ANDAHeritage Pharmaceuticals Inc.2015-07-07CALCIUM ACETATEORALCAPSULEANDA202315d48c66a9-26fe-4e1a-a68a-88afe83fb51d
5290330026ANDANostrum Laboratories, Inc.2015-10-26CALCIUM ACETATEORALCAPSULEANDA203179f5fa3aa9-79d9-49de-a486-1af17d89786d
6317220377ANDACamber Pharmaceuticals, Inc.2014-02-03CALCIUM ACETATEORALCAPSULEANDA20313516befe48-3e89-4c4b-91c2-0dc1a816b9c0
7651620590ANDAAmneal Pharmaceuticals2014-10-08CALCIUM ACETATEORALCAPSULEANDA2016585bbed4df-5883-49fc-adae-1af4073bb860
8681800134ANDALupin Pharmaceuticals, Inc.2015-09-09CALCIUM ACETATEORALCAPSULEANDA2021277cb328a4-69ab-45c9-a5ae-34f2304c59c4
9683820539ANDAZydus Pharmaceuticals (Usa) Inc.2015-07-07CALCIUM ACETATEORALCAPSULEANDA2023159197844e-011a-4995-b288-7dc64b041ee6
10762820377ANDAExelan Pharmaceuticals Inc.2014-04-14CALCIUM ACETATEORALCAPSULEANDA203135a5725f95-621e-425b-946d-434b3fec24eb

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006152303ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2008-02-26CALCIUM ACETATEORALCAPSULE000540088ANDA077728b881ed7e-3f5a-4eab-83ff-ea609143f0e8
2178560088ANDAAtlantic Biologicals Corps2008-02-26CALCIUM ACETATEORALCAPSULE000540088ANDA077728bd529f97-35a1-4701-ba67-7f5999f97a65
3422910189ANDAAvkare, Inc.2015-04-09CALCIUM ACETATEORALCAPSULE651620590ANDA201658c2389f56-6497-e036-d129-8a4870bca30c
4493490064ANDARemedyrepack Inc.2010-11-11CALCIUM ACETATEORALCAPSULE000540088ANDA0777280de74b07-85a3-4899-98d7-cf3fcfb03e8b
5502680148ANDAAvpak2015-11-16CALCIUM ACETATEORALCAPSULE651620590ANDA20165847587bd0-6b7a-ff12-0dfc-ee04e0cbd1b8
6538080216ANDAState Of Florida Doh Central Pharmacy2009-07-01CALCIUM ACETATEORALCAPSULE000540088ANDA0777285edaed4c-4294-418b-a3bd-28b17f67381f
7538080905NDA AUTHORIZED GENERICState Of Florida Doh Central Pharmacy2014-01-01CALCIUM ACETATEORALCAPSULE007812081NDA021160b02f8473-3220-4651-9c7f-993645f43a82
8538081001ANDAState Of Florida Doh Central Pharmacy2014-11-01CALCIUM ACETATEORALCAPSULE317220377ANDA2031352b6d52a5-8742-4dd4-a9d5-dd65544e13c1
9548683460PhosloNDAPhysicians Total Care, Inc.1997-08-272006-10-11CALCIUM ACETATEORALCAPSULE492300640NDA0211606b0e60bb-0e9a-45a7-8f92-a43d939f8deb
10548685691PhosloNDAPhysicians Total Care, Inc.2010-03-01CALCIUM ACETATEORALCAPSULE492300640NDA0211606b0e60bb-0e9a-45a7-8f92-a43d939f8deb
11551544961ANDACardinal Health2008-02-26CALCIUM ACETATEORALCAPSULE000540088ANDA077728a827ca04-f0d3-4e6d-84b2-932d7da06d8a
12551544984ANDACardinal Health2013-07-26CALCIUM ACETATEORALCAPSULE680840479ANDA0777287d2c303a-6772-4bdc-ae3a-2268adcc4913
13551547750PhosloNDACardinal Health2001-04-02CALCIUM ACETATEORALCAPSULE492300640NDA021160d7038a81-a9b9-4cc0-aafb-14e8eb608360
14581182081NDA AUTHORIZED GENERICClinical Solutions Wholesale2012-03-14CALCIUM ACETATEORALCAPSULE007812081NDA02116027f3f18d-375c-438b-9a24-15792975f261
15680840479ANDAAmerican Health Packaging2013-07-26CALCIUM ACETATEORALCAPSULE000540088ANDA0777281090762c-eec1-4ab0-9ddc-43caa764cd0e, bb5785a3-ba5b-43b6-9c65-07c56766a3eb
16762370280ANDAMckesson Contract Packaging2013-04-09CALCIUM ACETATEORALCAPSULE000540088ANDA0777284d201395-b244-423f-9f6b-91f88cca6971

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA077728CALCIUM ACETATEROXANE LABORATORIES INC2008-02-26ANDA077728_001
2ANDA091312CALCIUM ACETATEPADDOCK LABORATORIES LLC2012-06-01ANDA091312_001
3ANDA201658CALCIUM ACETATEAMNEAL PHARMACEUTICALS2014-10-06ANDA201658_001
4ANDA202127CALCIUM ACETATELUPIN LTD2015-07-09ANDA202127_001
5ANDA202315CALCIUM ACETATEHERITAGE PHARMACEUTICALS INC2015-06-29ANDA202315_001
6ANDA203135CALCIUM ACETATEINVAGEN PHARMACEUTICALS INC2013-02-07ANDA203135_001
7ANDA203179CALCIUM ACETATENOSTRUM LABORATORIES INC2015-10-26ANDA203179_001
8NDA021160PHOSLOFRESENIUS MEDICAL CARE NORTH AMERICA2001-04-02p6576665
p6875445, SUBSTANCE
NDA021160_001, NDA021160_002, NDA021160_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077728_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALCAPSULEFalseAB2008-02-26CALCIUM ACETATE
2ANDA091312_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALCAPSULEFalseAB2012-06-01CALCIUM ACETATE
3ANDA201658_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALCAPSULEFalseAB2014-10-06CALCIUM ACETATE
4ANDA202127_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALCAPSULEFalseAB2015-07-09CALCIUM ACETATE
5ANDA202315_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALCAPSULEFalseAB2015-06-29CALCIUM ACETATE
6ANDA203135_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALCAPSULEFalseAB2013-02-07CALCIUM ACETATE
7ANDA203179_001RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALCAPSULEFalseAB2015-10-26CALCIUM ACETATE
8NDA021160_001discontinuedCALCIUM ACETATE (EQ 84.5MG CALCIUM)ORALCAPSULEFalse2001-04-02PHOSLO
9NDA021160_002discontinuedCALCIUM ACETATE (EQ 169MG CALCIUM)ORALCAPSULEFalse2001-04-02PHOSLO
10NDA021160_003RXCALCIUM ACETATE (EQ 169MG CALCIUM)ORALCAPSULETrueAB2001-04-02PHOSLO

patent(s)

#idexpiration dateapplication(s)
1p6576665 (view patent)2021-04-03NDA021160
2p6875445 (view patent)2021-07-30NDA021160

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10de74b07-85a3-4899-98d7-cf3fcfb03e8b (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-11-1179493490064
21090762c-eec1-4ab0-9ddc-43caa764cd0e (view SPL)These highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. See full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-07-261680840479
316befe48-3e89-4c4b-91c2-0dc1a816b9c0 (view SPL)These highlights do not include all the information needed to use calcium acetate capsules safely and effectively. See full prescribing information for calcium acetate capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.manufacture2014-01-191317220377
427f3f18d-375c-438b-9a24-15792975f261 (view SPL)These highlights do not include all the information needed to use calcium acetate gelcaps safely and effectively. See full prescribing information for calcium acetate gelcaps.Calcium Acetate Gelcaps (calcium acetate): 667 mgInitial U.S. Approval: 1990prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2014-07-011581182081
52b6d52a5-8742-4dd4-a9d5-dd65544e13c1 (view SPL)These highlights do not include all the information needed to use calcium acetate capsules safely and effectively. See full prescribing information for calcium acetate capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-12-291538081001
634a29fae-b549-41ed-bd7d-e98fe2110bef (view SPL)PhosLo (calcium acetate)These highlights do not include all the information needed to use PhosLo safely and effectively. see full prescribing information for PhosLo. PhosLo (Calcium Acetate) CAPSULE for ORAL use.Initial U.S. Approval: 1990prescriptionHuman PrescriptionFresenius Medical Care North America2014-08-044492300640
747587bd0-6b7a-ff12-0dfc-ee04e0cbd1b8 (view SPL)These highlights do not include all the information needed to use calcium acetate safely and effectively. See full prescribing information for calcium acetate. CALCIUM acetate capsules: 667 mg, for oral useInitial U.S. Approval: 1990prescriptionHuman PrescriptionAvpak2015-11-161502680148
84d201395-b244-423f-9f6b-91f88cca6971 (view SPL)These highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. See full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionMckesson Contract PackagingREPACK2013-04-091762370280
94d5c8c68-2755-4d7c-b689-6c5e50ff1b26 (view SPL)These highlights do not include all the information needed to use calcium acetate gelcaps safely and effectively. See full prescribing information for calcium acetate gelcaps.Calcium Acetate Gelcaps (calcium acetate): 667 mgInitial U.S. Approval: 1990prescriptionHuman PrescriptionSandoz Inc2014-08-046007812081, 007812672
105bbed4df-5883-49fc-adae-1af4073bb860 (view SPL)These highlights do not include all the information needed to use calcium acetate safely and effectively. See full prescribing information for calcium acetate. CALCIUM acetate capsules: 667 mg, for oral useInitial U.S. Approval: 1990prescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2011-03-318651620590
115edaed4c-4294-418b-a3bd-28b17f67381f (view SPL)Calcium Acetate CapsulesprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-03-122538080216
126b0e60bb-0e9a-45a7-8f92-a43d939f8deb (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-03-103548683460, 548685691
137cb328a4-69ab-45c9-a5ae-34f2304c59c4 (view SPL)Calcium Acetate CapsulesThese highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. see full prescribing information for Calcium Acetate Capsules.CALCIUM Acetate Capsules for ORAL use.Initial U.S. Approval: 1990prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.manufacture2015-09-092681800134
147d2c303a-6772-4bdc-ae3a-2268adcc4913 (view SPL)These highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. See full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionCardinal HealthREPACK2014-08-052551544984
1585fd41f8-2823-44ca-a15e-f1f2e5d0ff94 (view SPL)These highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. See full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2013-07-035000540088
169197844e-011a-4995-b288-7dc64b041ee6 (view SPL)These highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. See full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules for ORAL use. Initial U.S. Approval: 1990prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.analysis, label, manufacture, pack2015-07-083683820539
17a5725f95-621e-425b-946d-434b3fec24eb (view SPL)These highlights do not include all the information needed to use calcium acetate capsules safely and effectively. See full prescribing information for calcium acetate capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionExelan Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2014-04-141762820377
18a827ca04-f0d3-4e6d-84b2-932d7da06d8a (view SPL)These highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. See full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionCardinal HealthREPACK2014-10-275551544961
19b02f8473-3220-4651-9c7f-993645f43a82 (view SPL)These highlights do not include all the information needed to use calcium acetate gelcaps safely and effectively. See full prescribing information for calcium acetate gelcaps.Calcium Acetate Gelcaps (calcium acetate): 667 mgInitial U.S. Approval: 1990prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-02-271538080905
20b881ed7e-3f5a-4eab-83ff-ea609143f0e8 (view SPL)These highlights do not include all the information needed to useCalcium Acetate Capsulessafely and effectively. See full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules, 667mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2015-05-0615006152303
21bb5785a3-ba5b-43b6-9c65-07c56766a3eb (view SPL)These highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. See full prescribing information for Calcium Acetate Capsules.Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionAmerican Health PackagingREPACK2012-09-141680840479
22bd529f97-35a1-4701-ba67-7f5999f97a65 (view SPL)These highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. See full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990prescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2011-04-277178560088
23c2389f56-6497-e036-d129-8a4870bca30c (view SPL)These highlights do not include all the information needed to use calcium acetate safely and effectively. See full prescribing information for calcium acetate. CALCIUM acetate capsules: 667 mg, for oral useInitial U.S. Approval: 1990prescriptionHuman PrescriptionAvkare, Inc.2015-04-091422910189
24d48c66a9-26fe-4e1a-a68a-88afe83fb51d (view SPL)These highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. See full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules for ORAL use. Initial U.S. Approval: 1990prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-07-013231550531
25d7038a81-a9b9-4cc0-aafb-14e8eb608360 (view SPL)Phoslo Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2011-08-301551547750
26f5fa3aa9-79d9-49de-a486-1af17d89786d (view SPL)Calcium Acetate CapsulesThese highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. see full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules for ORAL use.Initial U.S. Approval: 1990prescriptionHuman PrescriptionNostrum Laboratories, Inc.ANALYSIS, MANUFACTURE2015-10-292290330026

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