balsalazide Oral Tablet

Brand(s)
Giazo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Salix Pharmaceuticals, Inc. (2013-05-13)
Oldest Current Product
2012-02-02
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\BALSALAZIDE
FDAOB
ORAL\TABLET\BALSALAZIDE DISODIUM
SPL Active
ORAL\TABLET, FILM COATED\BALSALAZIDE DISODIUM
ORAL\TABLET\BALSALAZIDE DISODIUM
SPL Moiety
ORAL\TABLET, FILM COATED\BALSALAZIDE
ORAL\TABLET\BALSALAZIDE

product(s) by strength(s)

balsalazide disodium 1100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1656490102GiazoNDASalix Pharmaceuticals, Inc.2012-02-02BALSALAZIDE DISODIUMORALTABLET, FILM COATEDNDA022205fc5146c6-448b-44c9-bb06-8bdfe484f2f1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840367ANDAPar Pharmaceutical Companies, Inc.2015-07-01BALSALAZIDE DISODIUMORALTABLETANDA20633693064dc5-6748-4876-a32c-156438b09ac7

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA206336BALSALAZIDE DISODIUMPAR PHARMACEUTICAL INC2015-09-08ANDA206336_001
2NDA022205GIAZOVALEANT PHARMACEUTICALS INTERNATIONAL2012-02-03p7625884, TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
p7452872, TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
p8497256, TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
p6197341, TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS, SUBSTANCE
NEW DOSAGE FORM [2015-02-03]NDA022205_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA206336_001RXBALSALAZIDE DISODIUM (1.1GM)ORALTABLETFalseAB2015-09-08BALSALAZIDE DISODIUM
2NDA022205_001RXBALSALAZIDE DISODIUM (1.1GM)ORALTABLETTrueAB2012-02-03GIAZO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6197341 (view patent)2018-03-13NDA022205
2p7452872 (view patent)2026-08-24NDA022205, NDA020610balsalazide Oral Capsule
3p7625884 (view patent)2026-08-24NDA022205, NDA020610balsalazide Oral Capsule
4p8497256 (view patent)2031-06-23NDA022205

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
193064dc5-6748-4876-a32c-156438b09ac7 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use balsalazide disodium tablets safely and effectively. See full prescribing information for balsalazide disodium tablets. BALSALAZIDE disodium tablets, for oral use Initial U.S. Approval: 2000prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2015-03-171498840367
2fc5146c6-448b-44c9-bb06-8bdfe484f2f1 (view SPL)These highlights do not include all the information needed to useGIAZOsafely and effectively. See full prescribing information for GIAZO. GIAZO (balsalazide disodium) tablets, for oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionSalix Pharmaceuticals, Inc.2013-05-138656490102

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