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FDA NDA · NDA020228

ATROVENT

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA020228
TYPE
NDA
ORIGINAL APPROVAL
1993-09-29
LATEST ACTION
1999-08-18
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ATROVENT · ReferenceDiscontinued
IPRATROPIUM BROMIDE 0.02% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION

Approval history

1999-08-18Manufacturing (CMC) · Supplement 5 · priorityAP
1998-08-07Manufacturing (CMC) · Supplement 4 · priorityAP
1998-07-16Manufacturing (CMC) · Supplement 3 · priorityAP
1996-02-05Labeling · Supplement 1 · standardAP
1993-09-29Type 3 - New Dosage Form · Original · priority — Review ↗AP
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.

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