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FDA NDA · NDA212643

GALLIUM GA-68 PSMA-11

gallium ga-68 gozetotide

Sponsor: UNIV OF CA SAN FRAN

APPLICATION
NDA212643
TYPE
NDA
ORIGINAL APPROVAL
2020-12-01
LATEST ACTION
2022-06-16
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

GALLIUM GA 68 GOZETOTIDE · ReferencePrescription
GALLIUM GA-68 GOZETOTIDE 0.5-5mCi/mL · SOLUTION · INTRAVENOUS

Approval history

2022-06-16Labeling · Supplement 2 · standard — Label ↗AP
2021-11-17Labeling · Supplement 1 · standard — Letter ↗AP
2020-12-01Type 1 - New Molecular Entity · Original · standard — 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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