FDA
Epinastine Hydrochloride
The FDA lists this product in 7 strengths and forms.
Composition
- Active ingredients
- EPINASTINE HYDROCHLORIDE 0.05%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- EPINASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA204055-001 · Discontinued
- EPINASTINE HYDROCHLORIDE 0.05% · SolutionThis page
- EPINASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA090951-001 · Prescription
- EPINASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA091626-001 · Discontinued
- EPINASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA090870-001 · Discontinued
- EPINASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA203384-001 · Discontinued
- EPINASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA090919-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA090950.
At a glance
- Brand name
- Epinastine Hydrochloride
- Route
- Eye
- Dosage form
- Solution
- Applicant
- Sandoz
- Status
- Tentative approval
- FDA approval
- 27 Jan 2011
- Application
- ANDA090950-001