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FDA NDA · NDA202158

RADIOGENIX SYSTEM

Sponsor: NORTHSTAR MEDICAL

APPLICATION
NDA202158
TYPE
NDA
ORIGINAL APPROVAL
2018-02-08
LATEST ACTION
2021-07-19
ROUTE
INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

RADIOGENIX SYSTEM · ReferenceDiscontinued
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 30-1153mCi/GENERATOR · SOLUTION · INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC

Approval history

2021-07-19Labeling · Supplement 17 · standard — Label ↗AP
2020-12-28Manufacturing (CMC) · Supplement 15 · standard — Label ↗AP
2019-07-29Labeling · Supplement 9 · standard — Letter ↗AP
2018-05-22Labeling · Supplement 3 · standard — Label ↗AP
2018-03-09Labeling · Supplement 2 · standard — Letter ↗AP
2018-02-08Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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