balsalazide Oral Capsule

Brand(s)
Colazal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Oceanside Pharmaceuticals (2015-11-19)
Oldest Current Product
2000-07-18
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\BALSALAZIDE
FDAOB
ORAL\CAPSULE\BALSALAZIDE DISODIUM
SPL Active
ORAL\CAPSULE\BALSALAZIDE DISODIUM
SPL Moiety
ORAL\CAPSULE\BALSALAZIDE

product(s) by strength(s)

balsalazide disodium 750 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1656490101ColazalNDASalix Pharmaceuticals, Inc.2000-07-18BALSALAZIDE DISODIUMORALCAPSULENDA02061022f41e83-b9fb-4c9e-8cc3-f457034191a8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540079ANDARoxane Laboratories, Inc2007-12-28BALSALAZIDE DISODIUMORALCAPSULEANDA077806a0498308-14b2-4456-8e13-795f6fc8ea30
2003786750ANDAMylan Pharmaceuticals Inc.2007-12-28BALSALAZIDE DISODIUMORALCAPSULEANDA077807bb60806f-ec1d-40c1-b9f4-cf091d68adb6
3605052575ANDAApotex Corp2007-12-28BALSALAZIDE DISODIUMORALCAPSULEANDA077883f12ffa32-d14b-e9d9-e957-2ef08b64e8b4
4686820750NDA AUTHORIZED GENERICOceanside Pharmaceuticals2000-07-18BALSALAZIDE DISODIUMORALCAPSULENDA020610438d20fa-915d-4098-aa81-a768a7f64e47

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680102ANDAAvpak2014-11-06BALSALAZIDE DISODIUMORALCAPSULE605052575ANDA077883509b83b6-cde6-393b-8560-557793b6a529
2548686137ANDAPhysicians Total Care, Inc.2010-08-18BALSALAZIDE DISODIUMORALCAPSULE000540079ANDA0778063934dfa6-f2f7-4bdc-94fa-6c17224da61d
3551546775ColazalNDACardinal Health2000-07-18BALSALAZIDE DISODIUMORALCAPSULE656490101NDA020610fcab4c61-9bfd-40ad-8389-65e077abd787
4581180079ANDAClinical Solutions Wholesale2007-12-28BALSALAZIDE DISODIUMORALCAPSULE000540079ANDA0778062b52d057-2774-439f-962e-79a56d0579aa
5680840799ANDAAmerican Health Packaging2014-07-31BALSALAZIDE DISODIUMORALCAPSULE605052575ANDA0778837f9f32c4-35c0-4357-a141-5eb77ac6500c

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA077806BALSALAZIDE DISODIUMROXANE LABORATORIES INC2007-12-28ANDA077806_001
2ANDA077807BALSALAZIDE DISODIUMMYLAN PHARMACEUTICALS INC2007-12-28ANDA077807_001
3ANDA077883BALSALAZIDE DISODIUMAPOTEX INC ETOBICOKE SITE2007-12-28ANDA077883_001
4NDA020610COLAZALVALEANT PHARMACEUTICALS INTERNATIONAL2000-07-18p7625884, TREATMENT OF ULCERATIVE COLITIS
p7452872, TREATMENT OF ULCERATIVE COLITIS
NDA020610_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077806_001RXBALSALAZIDE DISODIUM (750MG)ORALCAPSULEFalseAB2007-12-28BALSALAZIDE DISODIUM
2ANDA077807_001RXBALSALAZIDE DISODIUM (750MG)ORALCAPSULEFalseAB2007-12-28BALSALAZIDE DISODIUM
3ANDA077883_001RXBALSALAZIDE DISODIUM (750MG)ORALCAPSULEFalseAB2007-12-28BALSALAZIDE DISODIUM
4NDA020610_001RXBALSALAZIDE DISODIUM (750MG)ORALCAPSULETrueAB2000-07-18COLAZAL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7452872 (view patent)2026-08-24NDA020610, NDA022205balsalazide Oral Tablet
2p7625884 (view patent)2026-08-24NDA020610, NDA022205balsalazide Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
122f41e83-b9fb-4c9e-8cc3-f457034191a8 (view SPL)These highlights do not include all the information needed to use COLAZAL safely and effectively. See full prescribing information for COLAZAL. COLAZAL (balsalazide disodium) Capsule for Oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionSalix Pharmaceuticals, Inc.MANUFACTURE2008-05-0111656490101
22b52d057-2774-439f-962e-79a56d0579aa (view SPL)These highlights do not include all the information needed to use Balsalazide Disodium Capsules USP, 750 mg safely and effectively. See full prescribing information for Balsalazide Disodium Capsules USP. Balsalazide Disodium Capsules USP for oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2014-07-011581180079
33934dfa6-f2f7-4bdc-94fa-6c17224da61d (view SPL)These highlights do not include all the information needed to use Balsalazide Disodium Capsules, 750 mg safely and effectively. See full prescribing information for Balsalazide Disodium Capsules. Balsalazide Disodium Capsules for oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-05-211548686137
4438d20fa-915d-4098-aa81-a768a7f64e47 (view SPL)These highlights do not include all the information needed to use Balsalazide Disodium safely and effectively. See full prescribing information for Balsalazide Disodium. Balsalazide Disodium Capsule for Oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2015-11-191686820750
5509b83b6-cde6-393b-8560-557793b6a529 (view SPL)These highlights do not include all the information needed to use Balsalazide Disodium Capsules, USP safely and effectively. See full prescribing information for balsalazide. Balsalazide Disodium Capsules, USP Initial U.S. Approval: 2000prescriptionHuman PrescriptionAvpak2014-11-061502680102
67f9f32c4-35c0-4357-a141-5eb77ac6500c (view SPL)These highlights do not include all the information needed to use Balsalazide Disodium Capsules, USP safely and effectively. See full prescribing information for balsalazide.BALSALAZIDE disodium capsules, USP for oral administrationInitial U.S. Approval: 2000prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-212680840799
7a0498308-14b2-4456-8e13-795f6fc8ea30 (view SPL)These highlights do not include all the information needed to use Balsalazide Disodium Capsules USP, 750 mg safely and effectively. See full prescribing information for Balsalazide Disodium Capsules USP. Balsalazide Disodium Capsules USP for oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-12-315000540079
8bb60806f-ec1d-40c1-b9f4-cf091d68adb6 (view SPL)These highlights do not include all the information needed to use balsalazide disodium capsules safely and effectively. See full prescribing information for balsalazide disodium capsules. BALSALAZIDE disodium capsules, USP for oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-02-284003786750
9f12ffa32-d14b-e9d9-e957-2ef08b64e8b4 (view SPL)These highlights do not include all the information needed to use BALSALAZIDE DISODIUM CAPSULES, USP safely and effectively. See full prescribing information for BALSALAZIDE DISODIUM CAPSULES, USP. BALSALAZIDE DISODIUM capsules, for oral administration Initial U.S. Approval: 2000prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-07-314605052575
10fcab4c61-9bfd-40ad-8389-65e077abd787 (view SPL)These highlights do not include all the information needed to use Colazal see full prescribing information for ColazalInitial U.S. Approval: 2000prescriptionHuman PrescriptionCardinal HealthREPACK2011-06-231551546775

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