# LOTEPREDNOL ETABONATE
> **ANDA216345** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2024-12-13
## Drug
- **FDA Application Number:** ANDA216345
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LOTEPREDNOL ETABONATE
- **Generic name:** LOTEPREDNOL ETABONATE
- **Active ingredients:** LOTEPREDNOL ETABONATE
- **Dosage form:** SUSPENSION/DROPS
- **Route:** OPHTHALMIC
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL
- **Manufacturer:** Amneal Pharmaceuticals NY LLC
- **First approval:** 2024-12-13
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216345)
---
*MORVS · CC0 1.0*