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GLATIRAMER ACETATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SCINOPHARM TAIWAN · Approved 2025-12-31

Drug application

FDA Application #
ANDA214741
Application type
Abbreviated New Drug Application (Generic)
Brand name
GLATIRAMER ACETATE
Generic name
GLATIRAMER ACETATE INJECTION
Active ingredients
GLATIRAMER ACETATE
Dosage form
INJECTABLE
Route
SUBCUTANEOUS
Marketing status
Prescription
Sponsor
SCINOPHARM TAIWAN
Manufacturer
UPSHER-SMITH LABORATORIES, LLC
First approval
2025-12-31

Source

Authoritative
Drugs@FDA application overview
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