balsalazide disodium
Drug Details
- Generic Name
- balsalazide disodium
- Brand Names
- balsalazide disodium
- Application Number
- ANDA217592
- Sponsor
- Zydus Lifesciences Limited
- NDC Codes
- 3
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- BALSALAZIDE DISODIUM
Indications and Usage
1 INDICATIONS AND USAGE Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Limitations of Use Safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. Balsalazide disodium capsules are an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. ( 1 ) Limitations of Use: Safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in children (ages 5 years to 17 years) and 12 weeks in adults have not been established. ( 1 )