FDA NDA · NDA021730

XOPENEX HFA

levalbuterol tartrate

Sponsor: LUPIN

APPLICATION

NDA021730

TYPE

NDA

ORIGINAL APPROVAL

2005-03-11

LATEST ACTION

2017-02-27

ROUTE

ORAL, INHALATION

DOSAGE FORM

AEROSOL, METERED

MARKETING STATUS

Prescription

Products

XOPENEX HFA · ReferencePrescription

LEVALBUTEROL TARTRATE EQ 0.045MG BASE/INH · AEROSOL, METERED · INHALATION

2017-02-27Labeling · Supplement 39 · standard — Label ↗AP

2016-01-22Manufacturing (CMC) · Supplement 38 · standardAP

2015-03-12Efficacy · Supplement 36 · standard — Pediatric Clinical Pharmacology Review ↗AP

2014-08-27Manufacturing (CMC) · Supplement 35 · standardAP

2013-11-25Manufacturing (CMC) · Supplement 34 · standardAP

2013-09-10Labeling · Supplement 33 · standard — Letter ↗AP

2013-03-14Manufacturing (CMC) · Supplement 32 · standardAP

2013-01-09Manufacturing (CMC) · Supplement 31 · standardAP

2012-12-07Manufacturing (CMC) · Supplement 29 · standardAP

2012-07-30Labeling · Supplement 24 · unknown — Label ↗AP

2008-02-05Manufacturing (CMC) · Supplement 8 — Letter ↗AP

2006-09-15Labeling · Supplement 3 · standard — Letter ↗AP

2006-04-04Labeling · Supplement 6 · standard — Letter ↗AP

2005-03-11Type 3 - New Dosage Form · Original · standard — Letter ↗AP

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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