APPLICATION
NDA020073
TYPE
NDA
ORIGINAL APPROVAL
1991-12-20
LATEST ACTION
2007-10-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ROMAZICON · ReferenceDiscontinued
FLUMAZENIL 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ROMAZICON · ReferenceDiscontinued
FLUMAZENIL 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-11-12Manufacturing (CMC) · Supplement 13 · priorityAP
2001-06-06Manufacturing (CMC) · Supplement 12 · priorityAP
2000-05-22Labeling · Supplement 10 · standardAP
1998-09-21Labeling · Supplement 8 · standardAP
1997-11-14Manufacturing (CMC) · Supplement 9 · priorityAP
1995-10-24Labeling · Supplement 3 · standardAP
1995-05-10Labeling · Supplement 4 · standardAP
1994-12-05Manufacturing (CMC) · Supplement 6 · priorityAP
1994-11-29Manufacturing (CMC) · Supplement 5 · priorityAP
1994-07-12Labeling · Supplement 7 · standardAP
1992-12-15Labeling · Supplement 2AP
1992-09-11Manufacturing (CMC) · Supplement 1 · priorityAP
1991-12-20Type 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.
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