APPLICATION
NDA019085
TYPE
NDA
ORIGINAL APPROVAL
1986-12-29
LATEST ACTION
2009-03-13
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
ATROVENTDiscontinued
IPRATROPIUM BROMIDE 0.018MG/INH · AEROSOL, METERED · INHALATION
Approval history
2009-03-13Labeling · Supplement 21 · standardAP
2009-03-13Labeling · Supplement 16 · standardAP
2001-08-27Manufacturing (CMC) · Supplement 20 · priorityAP
2000-09-22Manufacturing (CMC) · Supplement 19 · priorityAP
1999-08-18Manufacturing (CMC) · Supplement 18 · priorityAP
1998-11-03Manufacturing (CMC) · Supplement 17 · priorityAP
1997-11-26Manufacturing (CMC) · Supplement 15 · priorityAP
1997-01-15Manufacturing (CMC) · Supplement 9 · priorityAP
1996-12-03Labeling · Supplement 14 · standardAP
1996-06-10Manufacturing (CMC) · Supplement 8 · priorityAP
1996-04-10Manufacturing (CMC) · Supplement 3 · priorityAP
1996-01-29Labeling · Supplement 13 · standardAP
1995-01-04Manufacturing (CMC) · Supplement 6 · priorityAP
1994-06-13Labeling · Supplement 11 · standardAP
1994-05-19Manufacturing (CMC) · Supplement 10 · priorityAP
1994-02-25Labeling · Supplement 7 · standardAP
1994-01-31Manufacturing (CMC) · Supplement 12 · priorityAP
1992-03-25Manufacturing (CMC) · Supplement 5 · priorityAP
1989-03-16Labeling · Supplement 4AP
1988-04-27Manufacturing (CMC) · Supplement 1 · priorityAP
1988-04-21Manufacturing (CMC) · Supplement 2 · 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.