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FDA Orange Book · active-ingredient family

Balsalazide disodium

Balsalazide disodium is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GIAZO · NDA 022205

2

Brand (NDA)

6

Generics (ANDA)

6

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet

ProductApplicantApplicationTEApproved
GIAZORLDVALEANT PHARMS INTLNDA 022205—Feb 03, 2012
COLAZALRLDVALEANT PHARMS INTLNDA 020610ABJul 18, 2000

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
BALSALAZIDE DISODIUMCARNEGIEANDA 219422ABApr 03, 2025
BALSALAZIDE DISODIUMZYDUS LIFESCIENCESANDA 217592ABJun 08, 2023
BALSALAZIDE DISODIUMAARXION ANDA HLDINGANDA 206336—Sep 08, 2015
BALSALAZIDE DISODIUMAPOTEXANDA 077883ABDec 28, 2007
BALSALAZIDE DISODIUMHIKMAANDA 077806ABDec 28, 2007
BALSALAZIDE DISODIUMNOVITIUM PHARMAANDA 077807ABDec 28, 2007

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9192616Aug 02, 2026in 1 mo
U-1229
7625884Aug 24, 2026in 2 mo
U-141
7452872Aug 24, 2026in 2 mo
U-141
7452872*PEDFeb 24, 2027in 8 mo
7625884*PEDFeb 24, 2027in 8 mo
8497256Jun 23, 2031in 5 yr 1 mo
U-1229

Balsalazide disodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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