← FDA Drug Approvals (Drugs@FDA)

LOTEPREDNOL ETABONATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2023-08-09

Drug application

FDA Application #
ANDA215384
Application type
Abbreviated New Drug Application (Generic)
Brand name
LOTEPREDNOL ETABONATE
Generic name
Loteprednol Etabonate
Active ingredients
LOTEPREDNOL ETABONATE
Dosage form
GEL
Route
OPHTHALMIC
Marketing status
Prescription
Sponsor
SUN PHARM
First approval
2023-08-09

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown