balsalazide disodium
Drug Details
- Generic Name
- balsalazide disodium
- Brand Names
- balsalazide disodium
- Application Number
- ANDA217592
- Sponsor
- Zydus Pharmaceuticals (USA) Inc.
- 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 beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. Balsalazide is 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 beyond 8 weeks in children (ages 5 to 17 years) and 12 weeks in adults have not been established. ( 1 )