← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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