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LUTATHERA

NDA · New Drug Application · Sponsor: AAA USA INC · Approved 2018-01-26

Drug application

FDA Application #
NDA208700
Application type
New Drug Application
Brand name
LUTATHERA
Generic name
LUTETIUM LU 177 DOTATATE
Active ingredients
LUTETIUM LU 177 DOTATATE
Dosage form
SOLUTION
Route
INTRAVENOUS
Marketing status
Prescription
Sponsor
AAA USA INC
Manufacturer
Advanced Accelerator Applications USA, Inc
First approval
2018-01-26

Source

Authoritative
Drugs@FDA application overview
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