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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
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