# LOTEPREDNOL ETABONATE AND TOBRAMYCIN
> **ANDA217597** · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2025-12-10
## Drug
- **FDA Application Number:** ANDA217597
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LOTEPREDNOL ETABONATE AND TOBRAMYCIN
- **Generic name:** LOTEPREDNOL ETABONATE AND TOBRAMYCIN
- **Active ingredients:** LOTEPREDNOL ETABONATE; TOBRAMYCIN
- **Dosage form:** SUSPENSION/DROPS
- **Route:** OPHTHALMIC
- **Marketing status:** Prescription
- **Sponsor:** ALEMBIC
- **Manufacturer:** Alembic Pharmaceuticals Inc.
- **First approval:** 2025-12-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217597)
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