APPLICATION
NDA017688
TYPE
NDA
ORIGINAL APPROVAL
1977-03-08
LATEST ACTION
1996-06-24
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LASIX · ReferenceDiscontinued
FUROSEMIDE 10MG/ML · SOLUTION · ORAL
Approval history
1996-06-24Manufacturing (CMC) · Supplement 22 · standardAP
1995-05-01Manufacturing (CMC) · Supplement 21 · standardAP
1995-01-26Labeling · Supplement 18AP
1994-12-07Manufacturing (CMC) · Supplement 20 · standardAP
1993-08-26Manufacturing (CMC) · Supplement 19 · standardAP
1992-11-13Labeling · Supplement 17AP
1992-06-09Manufacturing (CMC) · Supplement 16 · standardAP
1991-12-19Manufacturing (CMC) · Supplement 11 · standardAP
1991-11-07Manufacturing (CMC) · Supplement 15 · standardAP
1991-10-23Labeling · Supplement 13AP
1991-05-23Manufacturing (CMC) · Supplement 14 · standardAP
1990-11-09Manufacturing (CMC) · Supplement 12 · standardAP
1990-05-18Manufacturing (CMC) · Supplement 10 · standardAP
1990-03-15Labeling · Supplement 6AP
1990-03-15Labeling · Supplement 9AP
1984-05-29Manufacturing (CMC) · Supplement 8 · standardAP
1982-08-23Manufacturing (CMC) · Supplement 7 · standardAP
1981-01-09Labeling · Supplement 5AP
1979-07-10Labeling · Supplement 4AP
1978-04-14Labeling · Supplement 3AP
1978-04-14Labeling · Supplement 1AP
1978-04-14Labeling · Supplement 2AP
1977-03-08Type 3 - New Dosage Form · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.