# PREDNISOLONE ACETATE
> **ANDA218256** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2025-06-11
## Drug
- **FDA Application Number:** ANDA218256
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PREDNISOLONE ACETATE
- **Generic name:** PREDNISOLONE ACETATE
- **Active ingredients:** PREDNISOLONE ACETATE
- **Dosage form:** SUSPENSION/DROPS
- **Route:** OPHTHALMIC
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL
- **Manufacturer:** Amneal Pharmaceuticals NY LLC
- **First approval:** 2025-06-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218256)
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