# LOTEPREDNOL ETABONATE
> **ANDA215384** · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2023-08-09
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215384)
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