← FDA Drug Approvals (Drugs@FDA)
GATIFLOXACIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CAPLIN · Approved 2021-11-03
Drug application
- FDA Application #
ANDA213542
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- GATIFLOXACIN
- Generic name
- GATIFLOXACIN
- Active ingredients
- GATIFLOXACIN
- Dosage form
- SOLUTION/DROPS
- Route
- OPHTHALMIC
- Marketing status
- Prescription
- Sponsor
- CAPLIN
- Manufacturer
- Leading Pharma, LLC
- First approval
- 2021-11-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown