APPLICATION
NDA016273
TYPE
NDA
ORIGINAL APPROVAL
1966-07-01
LATEST ACTION
2018-08-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LASIX · ReferenceDiscontinued
FUROSEMIDE 20MG · TABLET · ORAL
LASIX · ReferenceDiscontinued
FUROSEMIDE 80MG · TABLET · ORAL
LASIX · ReferenceDiscontinued
FUROSEMIDE 40MG · TABLET · ORAL
Approval history
1999-01-14Manufacturing (CMC) · Supplement 56 · priorityAP
1998-10-08Manufacturing (CMC) · Supplement 55 · priorityAP
1997-12-04Manufacturing (CMC) · Supplement 54 · priorityAP
1996-06-24Manufacturing (CMC) · Supplement 53 · priorityAP
1995-05-01Manufacturing (CMC) · Supplement 52 · priorityAP
1995-01-26Labeling · Supplement 51AP
1992-11-13Labeling · Supplement 50AP
1992-06-01Manufacturing (CMC) · Supplement 48 · priorityAP
1992-04-06Manufacturing (CMC) · Supplement 49 · priorityAP
1991-10-23Labeling · Supplement 47AP
1991-03-08Manufacturing (CMC) · Supplement 45 · priorityAP
1990-03-15Labeling · Supplement 46AP
1987-02-09Manufacturing (CMC) · Supplement 44 · priorityAP
1986-06-02Labeling · Supplement 38AP
1983-09-14Manufacturing (CMC) · Supplement 43 · priorityAP
1983-08-02Manufacturing (CMC) · Supplement 42 · priorityAP
1983-03-15Manufacturing (CMC) · Supplement 40 · priorityAP
1982-08-02Manufacturing (CMC) · Supplement 39 · priorityAP
1981-03-27Labeling · Supplement 35AP
1981-02-04Manufacturing (CMC) · Supplement 36 · priorityAP
1980-02-05Manufacturing (CMC) · Supplement 33 · priorityAP
1979-07-02Labeling · Supplement 34AP
1978-04-24Labeling · Supplement 28AP
1978-04-24Labeling · Supplement 30AP
1978-04-24Manufacturing (CMC) · Supplement 29 · priorityAP
1978-04-24Labeling · Supplement 31AP
1977-02-09Manufacturing (CMC) · Supplement 27 · priorityAP
1977-01-10Manufacturing (CMC) · Supplement 26 · priorityAP
1976-07-21Labeling · Supplement 23AP
1975-03-20REMS · Supplement 7 · priorityAP
1966-07-01Type 1 - New Molecular Entity · Original · priorityAP
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.