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SIMLANDI

BLA · Biologics License Application · Sponsor: ALVOTECH USA INC · Approved 2024-02-23

Drug application

FDA Application #
BLA761299
Application type
Biologics License Application
Brand name
SIMLANDI
Generic name
ADALIMUMAB-RYVK
Active ingredients
ADALIMUMAB-RYVK
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Sponsor
ALVOTECH USA INC
Manufacturer
Quallent Pharmaceuticals Health LLC
First approval
2024-02-23

Source

Authoritative
Drugs@FDA application overview
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