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/dropsANDA217770-001 · Prescription
- BEPOTASTINE BESILATE 1.5% · Solution/dropsANDA214588-001 · Prescription
- BEPOTASTINE BESILATE 1.5% · SolutionThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA206080.
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
- Applicant
- Sandoz Inc
- Status
- Tentative approval
- FDA approval
- 7 Jun 2017
- Application
- ANDA206080-001