Composition
- Active ingredients
- GATIFLOXACIN 0.5%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- GATIFLOXACIN 0.5% · Solution/dropsANDA213542-001 · Prescription
- GATIFLOXACIN 0.3% · Solution/dropsANDA079084-001 · Discontinued
- GATIFLOXACIN 0.3% · SolutionANDA203190-001 · Tentative approval
- GATIFLOXACIN 0.5% · Solution/dropsThis page
- GATIFLOXACIN 0.5% · Solution/dropsANDA204227-001 · Prescription
- GATIFLOXACIN 0.5% · Solution/dropsANDA206446-001 · Discontinued
- GATIFLOXACIN 0.5% · Solution/dropsANDA202653-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA203189.
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
- Gatifloxacin
- Route
- Eye
- Dosage form
- Solution/drops
- Applicant
- Hikma
- Status
- Discontinued
- FDA approval
- 3 Sept 2014
- Application
- ANDA203189-001