FDA NDA · NDA017243

ULTRA-TECHNEKOW V4

technetium tc-99m

Sponsor: CURIUM

APPLICATION

NDA017243

TYPE

NDA

ORIGINAL APPROVAL

1973-11-23

LATEST ACTION

2017-01-30

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription, Discontinued

Products

ULTRA-TECHNEKOW V4 · ReferencePrescription

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 1-19 CI/GENERATOR · SOLUTION · INTRAVENOUS

ULTRA-TECHNEKOW V4Discontinued

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 0.25-3 CI/GENERATOR · SOLUTION · INTRAVENOUS

Approval history

2017-01-30Manufacturing (CMC) · Supplement 47 · standardAP

2015-05-04Labeling · Supplement 46 · standard — Letter ↗AP

2015-02-16Manufacturing (CMC) · Supplement 45 · standardAP

2014-02-18Labeling · Supplement 43 · standard — Letter ↗AP

2013-12-20Labeling · Supplement 44 · standard — Letter ↗AP

2013-11-18Manufacturing (CMC) · Supplement 41 · standardAP

2013-06-21Manufacturing (CMC) · Supplement 36 · standardAP

2013-06-11Manufacturing (CMC) · Supplement 40 · standardAP

2013-05-13Manufacturing (CMC) · Supplement 37 · standardAP

2013-05-10Manufacturing (CMC) · Supplement 38 · standardAP

2013-03-15Manufacturing (CMC) · Supplement 39 · standardAP

2008-11-10Labeling · Supplement 30 · standardAP

2006-03-27Labeling · Supplement 28 · standard — Letter ↗AP

2004-10-15Manufacturing (CMC) · Supplement 25 · standard — Letter ↗AP

2003-01-16Manufacturing (CMC) · Supplement 22 · standard — Letter ↗AP

2002-04-19Manufacturing (CMC) · Supplement 21 · standardAP

2002-03-04Manufacturing (CMC) · Supplement 20 · standardAP

1999-12-29Manufacturing (CMC) · Supplement 19 · standardAP

1999-04-14Manufacturing (CMC) · Supplement 18 · standardAP

1998-11-20Manufacturing (CMC) · Supplement 17 · standardAP

1998-02-18Labeling · Supplement 16 · standardAP

1997-06-18Manufacturing (CMC) · Supplement 15 · standardAP

1997-03-21Manufacturing (CMC) · Supplement 13 · standardAP

1996-08-20Manufacturing (CMC) · Supplement 14 · standardAP

1996-07-16Manufacturing (CMC) · Supplement 12 · standardAP

1984-03-26Labeling · Supplement 10AP

1982-06-30Manufacturing (CMC) · Supplement 9 · standardAP

1982-05-07Manufacturing (CMC) · Supplement 8 · standardAP

1979-07-24Manufacturing (CMC) · Supplement 6 · standardAP

1977-08-23Manufacturing (CMC) · Supplement 5 · standardAP

1977-07-27Manufacturing (CMC) · Supplement 4 · standardAP

1976-10-08Manufacturing (CMC) · Supplement 3 · standardAP

1973-11-23Type 5 - New Formulation or New Manufacturer · Original · standardAP

VIEW ON DRUGS@FDA ↗

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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ULTRA-TECHNEKOW V4

Products

Approval history

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