# GLATIRAMER ACETATE
> **ANDA213382** · Abbreviated New Drug Application (Generic) · Sponsor: HYBIO · Approved 2026-02-11
## Drug
- **FDA Application Number:** ANDA213382
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** GLATIRAMER ACETATE
- **Generic name:** GLATIRAMER ACETATE
- **Active ingredients:** GLATIRAMER ACETATE
- **Dosage form:** INJECTABLE
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** HYBIO
- **Manufacturer:** AJENAT PHARMACEUTICALS LLC
- **First approval:** 2026-02-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213382)
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