APPLICATION
NDA016363
TYPE
NDA
ORIGINAL APPROVAL
1968-03-20
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LASIX · ReferenceDiscontinued
FUROSEMIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2007-12-07Efficacy · Supplement 31AP
2007-12-07Labeling · Supplement 21AP
2007-12-07Labeling · Supplement 16AP
1996-06-24Manufacturing (CMC) · Supplement 58 · priorityAP
1996-03-06Labeling · Supplement 56 · standardAP
1995-08-04Manufacturing (CMC) · Supplement 57 · priorityAP
1995-05-01Manufacturing (CMC) · Supplement 54 · priorityAP
1995-04-03Manufacturing (CMC) · Supplement 55 · priorityAP
1995-01-26Labeling · Supplement 48AP
1995-01-26Labeling · Supplement 53 · standardAP
1993-09-02Manufacturing (CMC) · Supplement 51 · priorityAP
1993-07-09Manufacturing (CMC) · Supplement 52 · priorityAP
1993-07-09Labeling · Supplement 50 · standardAP
1993-07-07Manufacturing (CMC) · Supplement 49 · priorityAP
1992-11-13Labeling · Supplement 47AP
1992-01-15Labeling · Supplement 46AP
1990-09-14Labeling · Supplement 45AP
1990-08-10Manufacturing (CMC) · Supplement 42 · priorityAP
1990-03-15Labeling · Supplement 43AP
1990-01-05Manufacturing (CMC) · Supplement 44 · priorityAP
1988-02-25Manufacturing (CMC) · Supplement 41 · priorityAP
1987-10-22Manufacturing (CMC) · Supplement 40 · priorityAP
1986-06-02Labeling · Supplement 33AP
1986-01-22Manufacturing (CMC) · Supplement 39 · priorityAP
1984-10-01Manufacturing (CMC) · Supplement 38 · priorityAP
1984-06-07Manufacturing (CMC) · Supplement 37 · priorityAP
1983-06-14Labeling · Supplement 35AP
1982-10-22Manufacturing (CMC) · Supplement 36 · priorityAP
1982-06-04Manufacturing (CMC) · Supplement 34 · priorityAP
1981-08-28Labeling · Supplement 32AP
1981-03-05Labeling · Supplement 29AP
1981-02-05Efficacy · Supplement 30AP
1979-11-12Manufacturing (CMC) · Supplement 26 · priorityAP
1979-08-21Manufacturing (CMC) · Supplement 20 · priorityAP
1979-07-02Labeling · Supplement 27AP
1979-06-25Manufacturing (CMC) · Supplement 28 · priorityAP
1979-02-22Labeling · Supplement 25AP
1979-02-22Labeling · Supplement 24AP
1978-04-14Labeling · Supplement 23AP
1978-04-14Labeling · Supplement 22AP
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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