← FDA DRUG APPROVALS

FDA NDA · NDA213227

DETECTNET

copper cu 64 dotatate

Sponsor: CURIUM

APPLICATION
NDA213227
TYPE
NDA
ORIGINAL APPROVAL
2020-09-03
LATEST ACTION
2021-12-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

DETECTNET · ReferencePrescription
COPPER CU-64 DOTATATE 4mL (1mCi/ML) · SOLUTION · INTRAVENOUS

Approval history

2021-12-22Labeling · Supplement 1 · standard — Letter ↗AP
2020-09-03Type 1 - New Molecular Entity · Original · priority — Letter ↗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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