FDA
Balsalazide Disodium
The FDA lists this product in 8 strengths and forms.
Composition
- Active ingredients
- BALSALAZIDE DISODIUM 1.1G
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BALSALAZIDE DISODIUM 1.1GM · TabletANDA206336-001 · Discontinued
- BALSALAZIDE DISODIUM 750MG · CapsuleANDA077806-001 · Prescription
- BALSALAZIDE DISODIUM 750MG · CapsuleANDA077807-001 · Prescription
- BALSALAZIDE DISODIUM 750MG · CapsuleANDA077883-001 · Prescription
- BALSALAZIDE DISODIUM 1.1GM · TabletANDA206529-001 · Tentative approval
- BALSALAZIDE DISODIUM 750MG · CapsuleANDA217592-001 · Prescription
- BALSALAZIDE DISODIUM 750MG · CapsuleANDA219422-001 · Prescription
- BALSALAZIDE DISODIUM 1.1G · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA206909.
At a glance
- Brand name
- Balsalazide Disodium
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Mylan Pharms Inc
- Status
- Tentative approval
- FDA approval
- 1 Sept 2015
- Application
- ANDA206909-001