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FDA NDA · NDA020393

ATROVENT

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA020393
TYPE
NDA
ORIGINAL APPROVAL
1995-10-20
LATEST ACTION
2015-05-11
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

ATROVENT · ReferenceDiscontinued
IPRATROPIUM BROMIDE 0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2015-05-11Manufacturing (CMC) · Supplement 14 · standardAP
2015-01-05Manufacturing (CMC) · Supplement 13 · standardAP
2011-02-02Labeling · Supplement 11 · unknown — Letter ↗AP
2007-12-04Labeling · Supplement 7 · standard — Label ↗AP
2003-05-23Labeling · Supplement 4 · standard — Label ↗AP
2000-01-27Manufacturing (CMC) · Supplement 2 · standardAP
1999-08-18Manufacturing (CMC) · Supplement 3 · standardAP
1998-04-01Efficacy · Supplement 1 · unknown — Letter ↗AP
1995-10-20Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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