BALSALAZIDE
BALSALAZIDE is listed in the FDA National Drug Code directory with 1 NDC code. Available dosage form: powder.
Drug Details
- Generic Name
- BALSALAZIDE
- Brand Names
- N/A
- Application Number
- Sponsor
- Signa S.A. de C.V.
- NDC Codes
- 1
- Dosage Forms
- POWDER
- Routes
- N/A
- 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)