← FDA Drug Approvals (Drugs@FDA)
GLATIRAMER ACETATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HYBIO · Approved 2026-02-11
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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