← FDA DRUG APPROVALS

FDA NDA · NDA020394

ATROVENT

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA020394
TYPE
NDA
ORIGINAL APPROVAL
1995-10-20
LATEST ACTION
2011-02-18
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

ATROVENT · ReferenceDiscontinued
IPRATROPIUM BROMIDE 0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2011-02-18Labeling · Supplement 12 · unknown — Letter ↗AP
2008-10-14Labeling · Supplement 8 · standard — Letter ↗AP
2003-05-23Labeling · Supplement 5 · standard — Letter ↗AP
2000-10-27Efficacy · Supplement 4 · unknown — Review ↗AP
2000-01-27Manufacturing (CMC) · Supplement 2 · standardAP
1999-08-18Manufacturing (CMC) · Supplement 3 · standardAP
1998-11-09Efficacy · Supplement 1 · standard — Review ↗AP
1995-10-20Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →