Pentosan Polysulfate Oral Capsule

Brand(s)
Elmiron
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2012-09-13)
Oldest Current Product
1996-09-26
License(s)
NDA
RxNORM
ORAL CAPSULE\PENTOSAN POLYSULFATE
FDAOB
ORAL\CAPSULE\PENTOSAN POLYSULFATE SODIUM
SPL Active
ORAL\CAPSULE, GELATIN COATED\PENTOSAN POLYSULFATE SODIUM
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\PENTOSAN POLYSULFATE

product(s) by strength(s)

pentosan polysulfate 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580098ElmironNDAJanssen Pharmaceuticals, Inc.1996-09-26PENTOSAN POLYSULFATE SODIUMORALCAPSULE, GELATIN COATEDNDA020193f0ba651e-3d8a-11df-8fbe-119855d89593

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684525ElmironNDAPhysicians Total Care, Inc.2003-12-17PENTOSAN POLYSULFATE SODIUMORALCAPSULE, GELATIN COATED50458009801NDA020193c7417e03-5812-4f35-8433-6062d68420fc
2551540553ElmironNDACardinal Health1996-09-26PENTOSAN POLYSULFATE SODIUMORALCAPSULE, GELATIN COATED504580098NDA0201933b172ad2-074f-4534-af1f-89d951647ee9

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020193ELMIRONJANSSEN PHARMACEUTICALS INC1996-09-26NDA020193_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020193_001RXPENTOSAN POLYSULFATE SODIUM (100MG)ORALCAPSULETrue1996-09-26ELMIRON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13b172ad2-074f-4534-af1f-89d951647ee9 (view SPL)ELMIRON-100 mg (pentosan polysulfate sodium) CapsulesprescriptionHuman PrescriptionCardinal HealthREPACK2014-07-014551540553
2c7417e03-5812-4f35-8433-6062d68420fc (view SPL)ELMIRON-100 mg (pentosan polysulfate sodium)CapsulesprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-03-082548684525
3f0ba651e-3d8a-11df-8fbe-119855d89593 (view SPL)ELMIRON-100 mg (pentosan polysulfate sodium) CapsulesprescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2012-09-137504580098

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