← FDA DRUG APPROVALS

FDA NDA · NDA208547

NETSPOT

68ga-dotatate

Sponsor: NOVARTIS

APPLICATION
NDA208547
TYPE
NDA
ORIGINAL APPROVAL
2016-06-01
LATEST ACTION
2023-10-26
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

NETSPOT · ReferencePrescription
GALLIUM DOTATATE GA-68 2.1-5.5mCi/ML · POWDER · INTRAVENOUS

Approval history

2023-10-26Labeling · Supplement 27 · standard — Letter ↗AP
2021-12-22Labeling · Supplement 24 · standard — Letter ↗AP
2021-06-22Labeling · Supplement 22 · standard — Letter ↗AP
2021-06-22Labeling · Supplement 20 · standard — Letter ↗AP
2018-09-27Manufacturing (CMC) · Supplement 12AP
2018-08-09Manufacturing (CMC) · Supplement 13AP
2018-04-12Labeling · Supplement 11 · standard — Label ↗AP
2017-01-20Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2016-10-31Manufacturing (CMC) · Supplement 3 · standardAP
2016-09-02Labeling · Supplement 2 · standard — Label ↗AP
2016-06-01Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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