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FDA NDA · NDA020837

XOPENEX

Sponsor: HIKMA

APPLICATION
NDA020837
TYPE
NDA
ORIGINAL APPROVAL
1999-03-25
LATEST ACTION
2019-01-03
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

XOPENEX · ReferenceDiscontinued
LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION
XOPENEX · ReferenceDiscontinued
LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION
XOPENEX · ReferenceDiscontinued
LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION
XOPENEX · ReferenceDiscontinued
LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION

Approval history

2019-01-03Labeling · Supplement 44 · standard — Letter ↗AP
2015-03-31Labeling · Supplement 43 · standard — Letter ↗AP
2015-01-22Efficacy · Supplement 41 · standard — Letter ↗AP
2014-12-15Manufacturing (CMC) · Supplement 42 · standardAP
2014-03-31Labeling · Supplement 39 · standard — Letter ↗AP
2014-01-15Labeling · Supplement 40 · standard — Letter ↗AP
2013-09-20Labeling · Supplement 38 · standard — Letter ↗AP
2013-01-09Manufacturing (CMC) · Supplement 37 · standardAP
2013-01-09Manufacturing (CMC) · Supplement 35 · standardAP
2012-09-07Labeling · Supplement 36 · unknown — Label ↗AP
2006-09-07Labeling · Supplement 20 · standard — Letter ↗AP
2003-07-18Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
2002-08-07Manufacturing (CMC) · Supplement 8 · standardAP
2002-03-04Manufacturing (CMC) · Supplement 7 · standardAP
2002-01-30Efficacy · Supplement 6 · standard — Label ↗AP
2001-02-16Manufacturing (CMC) · Supplement 5 · standardAP
2000-12-04Manufacturing (CMC) · Supplement 4 · standardAP
2000-04-12Manufacturing (CMC) · Supplement 3 · standardAP
1999-09-21Manufacturing (CMC) · Supplement 1 · standardAP
1999-03-25Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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