FDA
Bepotastine Besilate
The FDA lists this product in 5 strengths and forms.
Composition
- Active ingredients
- BEPOTASTINE BESILATE 1.5%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BEPOTASTINE BESILATE 1.5% · Solution/dropsANDA206220-001 · Prescription
- BEPOTASTINE BESILATE 1.5% · Solution/dropsANDA206066-001 · Discontinued
- BEPOTASTINE BESILATE 1.5% · Solution/dropsThis page
- BEPOTASTINE BESILATE 1.5% · Solution/dropsANDA214588-001 · Prescription
- BEPOTASTINE BESILATE 1.5% · SolutionANDA206080-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA217770.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Bepotastine Besilate
- Route
- Eye
- Dosage form
- Solution/drops
- Applicant
- Somerset Theraps LLC
- Status
- Prescription
- FDA approval
- 14 Aug 2024
- Application
- ANDA217770-001