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FDA NDA · NDA017697

KINEVAC

sincalide

Sponsor: BRACCO

APPLICATION
NDA017697
TYPE
NDA
ORIGINAL APPROVAL
1976-07-21
LATEST ACTION
2023-10-17
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

KINEVAC · ReferencePrescription
SINCALIDE 0.005MG/VIAL · POWDER · INTRAVENOUS

Approval history

2023-10-17Labeling · Supplement 38 · standard — Letter ↗AP
2018-12-18Labeling · Supplement 33 · standard — Label ↗AP
2018-03-21Labeling · Supplement 32 · standard — Letter ↗AP
2018-02-09Labeling · Supplement 31 · standard — Letter ↗AP
2016-02-17Manufacturing (CMC) · Supplement 27 · priority — Review ↗AP
2015-08-18Manufacturing (CMC) · Supplement 26 · priorityAP
2015-05-29Manufacturing (CMC) · Supplement 25 · priorityAP
2015-01-22Manufacturing (CMC) · Supplement 24 · priorityAP
2014-07-18Manufacturing (CMC) · Supplement 23 · priorityAP
2005-04-26Labeling · Supplement 17 · standard — Letter ↗AP
2002-11-27Manufacturing (CMC) · Supplement 14 · priority — Letter ↗AP
2002-11-27Manufacturing (CMC) · Supplement 12 · priority — Letter ↗AP
2002-11-27Manufacturing (CMC) · Supplement 15 · priority — Review ↗AP
2002-11-27Manufacturing (CMC) · Supplement 13 · priority — Letter ↗AP
2002-10-29Manufacturing (CMC) · Supplement 11 · priorityAP
1992-12-22Labeling · Supplement 10AP
1988-05-25Labeling · Supplement 9AP
1986-08-25Efficacy · Supplement 5AP
1985-07-15Manufacturing (CMC) · Supplement 6 · priorityAP
1979-10-18Manufacturing (CMC) · Supplement 4 · priorityAP
1977-09-14Manufacturing (CMC) · Supplement 1 · priorityAP
1976-07-21Type 1 - New Molecular Entity · Original · priorityAP
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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