patiromer Powder for Oral Suspension

Brand(s)
Veltassa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Relypsa, Inc. (2015-10-23)
Oldest Current Product
2015-10-23
License(s)
NDA
RxNORM
POWDER FOR ORAL SUSPENSION\PATIROMER
FDAOB
ORAL\POWDER\PATIROMER SORBITEX CALCIUM
SPL Active
ORAL\POWDER, FOR SUSPENSION\PATIROMER
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\PATIROMER

product(s) by strength(s)

patiromer 16800 mg powder for oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1534360168VeltassaNDARelypsa, Inc.2015-10-23PATIROMERORALPOWDER, FOR SUSPENSIONNDA205739bf002984-d6c9-46df-aecb-a07733f763c1

patiromer 25200 mg powder for oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1534360252VeltassaNDARelypsa, Inc.2015-10-23PATIROMERORALPOWDER, FOR SUSPENSIONNDA205739bf002984-d6c9-46df-aecb-a07733f763c1

patiromer 8400 mg powder for oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1534360084VeltassaNDARelypsa, Inc.2015-10-23PATIROMERORALPOWDER, FOR SUSPENSIONNDA205739bf002984-d6c9-46df-aecb-a07733f763c1

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA205739VELTASSARELYPSA INC2015-10-21NEW CHEMICAL ENTITY [2020-10-21]NDA205739_001, NDA205739_002, NDA205739_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205739_001RXPATIROMER SORBITEX CALCIUM (EQ 8.4GM BASE/PACKET)ORALPOWDERFalse2015-10-21VELTASSA
2NDA205739_002RXPATIROMER SORBITEX CALCIUM (EQ 16.8GM BASE/PACKET)ORALPOWDERFalse2015-10-21VELTASSA
3NDA205739_003RXPATIROMER SORBITEX CALCIUM (EQ 25.2GM BASE/PACKET)ORALPOWDERTrue2015-10-21VELTASSA

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1bf002984-d6c9-46df-aecb-a07733f763c1 (view SPL)These highlights do not include all the information needed to use VELTASSA safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspensionInitial U.S. Approval: 2015prescriptionHuman PrescriptionRelypsa, Inc.2015-10-234534360084, 534360168, 534360252

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