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FDA NDA · NDA018150

THALLOUS CHLORIDE TL 201

thallous chloride, tl 201

Sponsor: CURIUM

APPLICATION
NDA018150
TYPE
NDA
ORIGINAL APPROVAL
1979-10-23
LATEST ACTION
2025-12-10
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

THALLOUS CHLORIDE TL 201 · ReferencePrescription
THALLOUS CHLORIDE TL-201 1mCi/ML · INJECTABLE · INJECTION

Approval history

2025-12-10Labeling · Supplement 29 · standard — Letter ↗AP
2016-07-13Labeling · Supplement 27 · standard — Label ↗AP
2012-01-12Labeling · Supplement 26 · unknown — Letter ↗AP
2011-06-22Labeling · Supplement 25 · unknown — Letter ↗AP
2004-07-23Efficacy · Supplement 19 · unknown — Review ↗AP
2004-04-16Manufacturing (CMC) · Supplement 20 · standard — Letter ↗AP
2002-09-27Manufacturing (CMC) · Supplement 15 · standardAP
2002-06-03Manufacturing (CMC) · Supplement 16 · standardAP
1999-11-22Labeling · Supplement 13 · standardAP
1997-02-18Labeling · Supplement 12 · standardAP
1994-03-30Manufacturing (CMC) · Supplement 11 · standardAP
1993-12-16Efficacy · Supplement 10AP
1988-07-13Labeling · Supplement 9AP
1984-09-12Manufacturing (CMC) · Supplement 6 · standardAP
1982-05-07Manufacturing (CMC) · Supplement 3 · standardAP
1981-11-27Manufacturing (CMC) · Supplement 5 · standardAP
1980-05-13Manufacturing (CMC) · Supplement 1 · standardAP
1979-10-23Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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