← FDA Drug Approvals (Drugs@FDA)
FLUOROMETHOLONE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2024-01-09
Drug application
- FDA Application #
ANDA216348
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FLUOROMETHOLONE
- Generic name
- FLUOROMETHOLONE
- Active ingredients
- FLUOROMETHOLONE
- Dosage form
- SUSPENSION/DROPS
- Route
- OPHTHALMIC
- Marketing status
- Prescription
- Sponsor
- AMNEAL
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- First approval
- 2024-01-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown