Sodium polystyrene sulfonate Oral Suspension

Brand(s)
Kayexalate, Kionex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Covis Pharmaceuticals, Inc. (2013-08-08)
Oldest Current Product
1983-01-01
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\SODIUM POLYSTYRENE SULFONATE
FDAOB
ORAL, RECTAL\POWDER\SODIUM POLYSTYRENE SULFONATE\rdfq
ORAL, RECTAL\SUSPENSION\SODIUM POLYSTYRENE SULFONATE\rdfq
SPL Active
ORAL\POWDER, FOR SUSPENSION\SODIUM POLYSTYRENE SULFONATE
ORAL\POWDER\SODIUM POLYSTYRENE SULFONATE
ORAL\SUSPENSION\SODIUM POLYSTYRENE SULFONATE
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\POLYSTYRENE SULFONIC ACID
ORAL\POWDER, FOR SUSPENSION\SODIUM CATION
ORAL\POWDER\POLYSTYRENE SULFONIC ACID
ORAL\SUSPENSION\POLYSTYRENE SULFONIC ACID

product(s) by strength(s)

sodium polystyrene sulfonate 250 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1249870075KayexalateNDACovis Pharmaceuticals, Inc.2013-07-15SODIUM POLYSTYRENE SULFONATEORALPOWDER, FOR SUSPENSIONNDA011287e7808d28-9d96-4dde-81bc-5c8357cba004

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540379ANDARoxane Laboratories, Inc2013-06-17SODIUM POLYSTYRENE SULFONATEORALSUSPENSIONANDA08904983f3f990-4fab-43c7-9100-092d64ab6213
2005742002KionexANDAPaddock Laboratories, Llc2008-12-30SODIUM POLYSTYRENE SULFONATEORALSUSPENSIONANDA040028b916f972-10be-4e14-8603-087955fa9ad7
3005742003ANDAPaddock Laboratories, Llc2011-09-21SODIUM POLYSTYRENE SULFONATEORALSUSPENSIONANDA090590085fa3d6-b4fa-4734-8f44-d8282d0225a3
4005742004KionexANDAPaddock Laboratories, Llc1998-02-01SODIUM POLYSTYRENE SULFONATEORALPOWDER, FOR SUSPENSIONANDA040029d506116f-16a3-4f58-a432-7606c2179c9e
5009046041ANDAMajor2009-11-18SODIUM POLYSTYRENE SULFONATEORALPOWDERANDA040905dfced9d3-10af-493e-ad30-8034f39616fe
6107020036ANDAKvk-Tech, Inc.2012-07-25SODIUM POLYSTYRENE SULFONATEORALPOWDERANDA040905905c3ee5-d1a7-4deb-a345-4a42296704fa
7428060013ANDAEpic Pharma, Llc2014-04-14SODIUM POLYSTYRENE SULFONATEORALPOWDER, FOR SUSPENSIONANDA20233361cc890b-eb3d-494c-ae45-629a27e721ce
8428080500ANDAExact-Rx, Inc.2012-04-01SODIUM POLYSTYRENE SULFONATEORALPOWDER, FOR SUSPENSIONANDA0903131e807f60-56dd-4f10-bf7b-4bdefb52f343
9462870006ANDACarolina Medical Products Company1983-01-01SODIUM POLYSTYRENE SULFONATEORALSUSPENSIONANDA08785912d48dcf-07bd-4b06-bd6c-7543f1be8357
10462870012ANDACarolina Medical Products Company1989-01-19SODIUM POLYSTYRENE SULFONATEORALPOWDER, FOR SUSPENSIONANDA0899102017bfbe-cda8-46f1-b4f1-9c086c3249a9
11693150205ANDALeading Pharma, Llc2015-08-12SODIUM POLYSTYRENE SULFONATEORALPOWDER, FOR SUSPENSIONANDA204071b2bfd26e-9bc9-4e57-b5b8-efa03283dd2e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551547353ANDACardinal Health1983-01-01SODIUM POLYSTYRENE SULFONATEORALSUSPENSION462870006ANDA0878593c3b02a3-9a75-40a5-889d-97318faf881f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040028KIONEXPADDOCK LABORATORIES LLC2007-09-17ANDA040028_001
2ANDA040029KIONEXPADDOCK LABORATORIES LLC1998-02-06ANDA040029_001
3ANDA040905KALEXATEKVK TECH INC2009-03-30ANDA040905_001, ANDA040905_002
4ANDA040909SODIUM POLYSTYRENE SULFONATETrueCITRUSPHRMA LLC2008-12-03ANDA040909_001
5ANDA087859SPSCAROLINA MEDICAL PRODUCTS CO1982-12-08ANDA087859_001
6ANDA088453SODIUM POLYSTYRENE SULFONATETrueROXANE LABORATORIES INC1983-11-17ANDA088453_001
7ANDA088717SODIUM POLYSTYRENE SULFONATETrueMORTON GROVE PHARMACEUTICALS INC1984-09-11ANDA088717_001
8ANDA088786SODIUM POLYSTYRENE SULFONATETrueWOCKHARDT EU OPERATIONS (SWISS) AG1984-09-11ANDA088786_001
9ANDA089049SODIUM POLYSTYRENE SULFONATEROXANE LABORATORIES INC1986-11-17ANDA089049_001
10ANDA089910SODIUM POLYSTYRENE SULFONATECAROLINA MEDICAL PRODUCTS CO1989-01-19ANDA089910_001
11ANDA090313SODIUM POLYSTYRENE SULFONATECEDAR PHARMACEUTICALS LLC2011-12-21ANDA090313_001
12ANDA090590SODIUM POLYSTYRENE SULFONATEPADDOCK LABORATORIES LLC2011-05-13ANDA090590_001
13ANDA202333SODIUM POLYSTYRENE SULFONATEEPIC PHARMA LLC2014-03-19ANDA202333_001
14ANDA204071SODIUM POLYSTYRENE SULFONATENUVO PHARMACEUTICAL INC2014-11-28ANDA204071_001, ANDA204071_002
15NDA011287KAYEXALATECONCORDIA PHARMACEUTICALS INCNDA011287_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040028_001RXSODIUM POLYSTYRENE SULFONATE (15GM/60ML)SUSPENSIONFalseAA2007-09-17KIONEX
2ANDA040029_001RXSODIUM POLYSTYRENE SULFONATE (454GM/BOT)POWDERFalseAA1998-02-06KIONEX
3ANDA040905_001RXSODIUM POLYSTYRENE SULFONATE (454GM/BOT)POWDERFalseAA2009-03-30KALEXATE
4ANDA040905_002RXSODIUM POLYSTYRENE SULFONATE (15GM/BOT)POWDERFalse2015-04-03KALEXATE
5ANDA040909_001discontinuedSODIUM POLYSTYRENE SULFONATE (454GM/BOT)POWDERFalse2008-12-03SODIUM POLYSTYRENE SULFONATE
6ANDA087859_001RXSODIUM POLYSTYRENE SULFONATE (15GM/60ML)SUSPENSIONTrueAA1982-12-08SPS
7ANDA088453_001discontinuedSODIUM POLYSTYRENE SULFONATE (15GM/60ML)SUSPENSIONFalse1983-11-17SODIUM POLYSTYRENE SULFONATE
8ANDA088717_001discontinuedSODIUM POLYSTYRENE SULFONATE (15GM/60ML)SUSPENSIONFalse1984-09-11SODIUM POLYSTYRENE SULFONATE
9ANDA088786_001discontinuedSODIUM POLYSTYRENE SULFONATE (453.6GM/BOT)POWDERFalse1984-09-11SODIUM POLYSTYRENE SULFONATE
10ANDA089049_001RXSODIUM POLYSTYRENE SULFONATE (15GM/60ML)SUSPENSIONFalseAA1986-11-17SODIUM POLYSTYRENE SULFONATE
11ANDA089910_001RXSODIUM POLYSTYRENE SULFONATE (454GM/BOT)POWDERFalseAA1989-01-19SODIUM POLYSTYRENE SULFONATE
12ANDA090313_001RXSODIUM POLYSTYRENE SULFONATE (453.6GM/BOT)POWDERFalseAA2011-12-21SODIUM POLYSTYRENE SULFONATE
13ANDA090590_001RXSODIUM POLYSTYRENE SULFONATE (15GM/60ML)SUSPENSIONFalseAA2011-05-13SODIUM POLYSTYRENE SULFONATE
14ANDA202333_001RXSODIUM POLYSTYRENE SULFONATE (453.6GM/BOT)POWDERFalseAA2014-03-19SODIUM POLYSTYRENE SULFONATE
15ANDA204071_001RXSODIUM POLYSTYRENE SULFONATE (454GM/BOT)POWDERFalseAA2014-11-28SODIUM POLYSTYRENE SULFONATE
16ANDA204071_002RXSODIUM POLYSTYRENE SULFONATE (15GM/BOT)POWDERFalse2014-11-28SODIUM POLYSTYRENE SULFONATE
17NDA011287_001RXSODIUM POLYSTYRENE SULFONATE (453.6GM/BOT)POWDERTrueAAKAYEXALATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1085fa3d6-b4fa-4734-8f44-d8282d0225a3 (view SPL)Sodium Polystyrene Sulfonate Suspension, USP Sorbitol Free Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-07-015005742003
212d48dcf-07bd-4b06-bd6c-7543f1be8357 (view SPL)SPS SUSPENSION Sodium Polystyrene Sulfonate Suspension, USPCation-Exchange ResinRx OnlyprescriptionHuman PrescriptionCarolina Medical Products Company2011-03-213462870006
31e807f60-56dd-4f10-bf7b-4bdefb52f343 (view SPL)Sodium Polystyrene Sulfonate Powder for Suspension Cation - Exchange Resin Rx onlyprescriptionHuman PrescriptionExact-Rx, Inc.2015-01-124428080500
42017bfbe-cda8-46f1-b4f1-9c086c3249a9 (view SPL)SODIUM POLYSTYRENE SULFONATE FOR SUSPENSIONCation-Exchange ResinRx OnlyprescriptionHuman PrescriptionCarolina Medical Products CompanyANALYSIS, LABEL, MANUFACTURE, PACK2012-10-112462870012
53c3b02a3-9a75-40a5-889d-97318faf881f (view SPL)SPS SUSPENSION Sodium Polystyrene Sulfonate Suspension, USPCation-Exchange ResinRx OnlyprescriptionHuman PrescriptionCardinal HealthREPACK2015-10-012551547353
661cc890b-eb3d-494c-ae45-629a27e721ce (view SPL)SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION Rx OnlyprescriptionHuman PrescriptionEpic Pharma, Llc2015-05-016428060013
783f3f990-4fab-43c7-9100-092d64ab6213 (view SPL)SODIUM POLYSTYRENE SULFONATE Suspension, USPprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2013-06-153000540379
8905c3ee5-d1a7-4deb-a345-4a42296704fa (view SPL)SODIUM POLYSTYRENE SULFONATE, USPprescriptionHuman PrescriptionKvk-Tech, Inc.MANUFACTURE2015-07-304107020036
9b2bfd26e-9bc9-4e57-b5b8-efa03283dd2e (view SPL)Sodium Polystyrene Sulfonate for SuspensionprescriptionHuman PrescriptionLeading Pharma, Llc2015-08-121693150205
10b916f972-10be-4e14-8603-087955fa9ad7 (view SPL)Kionex Sodium PolystyreneSulfonate Suspension USPprescriptionHuman PrescriptionPaddock Laboratories, LlcMANUFACTURE2013-10-097005742002
11d506116f-16a3-4f58-a432-7606c2179c9e (view SPL)Kionex Sodium Polystyrene Sulfonate, USPprescriptionHuman PrescriptionPaddock Laboratories, LlcAPI MANUFACTURE, PACK2012-01-318005742004
12dfced9d3-10af-493e-ad30-8034f39616fe (view SPL)Kionex Sodium Polystyrene Sulfonate, USPprescriptionHuman PrescriptionMajor2012-04-092009046041
13e7808d28-9d96-4dde-81bc-5c8357cba004 (view SPL)Kayexalate SODIUM POLYSTYRENE SULFONATE, USP Cation-Exchange ResinprescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2013-08-082249870075

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