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FDA NDA · NDA208700

LUTATHERA

lutetium lu 177 dotatate

Sponsor: AAA USA INC

APPLICATION
NDA208700
TYPE
NDA
ORIGINAL APPROVAL
2018-01-26
LATEST ACTION
2024-11-26
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LUTATHERA · ReferencePrescription
LUTETIUM LU 177 DOTATATE 10mCi/ML · SOLUTION · INTRAVENOUS

Approval history

2024-11-26Labeling · Supplement 32 · standard — Letter ↗AP
2024-04-23Efficacy · Supplement 31 · priority — Label ↗AP
2023-03-07Labeling · Supplement 26 · standard — Label ↗AP
2022-06-13Efficacy · Supplement 19 · standard — Letter ↗AP
2022-06-13Labeling · Supplement 23 · standard — Letter ↗AP
2022-06-06Labeling · Supplement 20 · standard — Letter ↗AP
2020-05-29Efficacy · Supplement 1 · standard — Label ↗AP
2020-05-28Efficacy · Supplement 10 · standard — Letter ↗AP
2018-01-26Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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