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FDA NDA · NDA017858

KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID

technetium tc 99m sulfur colloid

Sponsor: SUN PHARM INDS INC

APPLICATION
NDA017858
TYPE
NDA
ORIGINAL APPROVAL
1978-04-17
LATEST ACTION
2019-12-19
ROUTE
INJECTION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

AN-SULFUR COLLOID · ReferencePrescription
TECHNETIUM TC-99M SULFUR COLLOID KIT N/A · SOLUTION · INJECTION, ORAL

Approval history

2019-12-19Labeling · Supplement 49 · standard — Label ↗AP
2016-04-22Manufacturing (CMC) · Supplement 40 · standardAP
2015-12-04Manufacturing (CMC) · Supplement 45 · standardAP
2015-09-28Manufacturing (CMC) · Supplement 44 · standardAP
2015-09-22Manufacturing (CMC) · Supplement 43 · standardAP
2015-08-13Manufacturing (CMC) · Supplement 42 · standardAP
2014-09-12Manufacturing (CMC) · Supplement 39 · standardAP
2013-12-04Manufacturing (CMC) · Supplement 38 · standardAP
2012-12-14Manufacturing (CMC) · Supplement 37 · standardAP
2012-08-13Efficacy · Supplement 35 · standard — Letter ↗AP
2011-07-22Efficacy · Supplement 34 · standard — Label ↗AP
2002-09-13Labeling · Supplement 24 · standard — Letter ↗AP
1998-08-04Manufacturing (CMC) · Supplement 23 · standardAP
1995-08-25Manufacturing (CMC) · Supplement 21 · standardAP
1989-09-22Labeling · Supplement 20AP
1986-09-12Efficacy · Supplement 15AP
1986-04-02Manufacturing (CMC) · Supplement 19 · standardAP
1985-08-02Manufacturing (CMC) · Supplement 17 · standardAP
1985-04-29Manufacturing (CMC) · Supplement 14 · standardAP
1985-02-26Labeling · Supplement 7AP
1984-09-10Manufacturing (CMC) · Supplement 12 · standardAP
1982-06-30Manufacturing (CMC) · Supplement 4 · standardAP
1982-01-27Labeling · Supplement 2AP
1982-01-11Labeling · Supplement 5AP
1981-11-16Manufacturing (CMC) · Supplement 8 · standardAP
1980-05-11Manufacturing (CMC) · Supplement 1 · standardAP
1978-04-17Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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