balsalazide disodium
balsalazide disodium is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including balsalazide disodium. Available dosage form: capsule.
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 a locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. (1) 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)