← 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