FDA NDA · NDA021247

AEROSPAN HFA

Sponsor: PHARMOBEDIENT

APPLICATION

NDA021247

TYPE

NDA

ORIGINAL APPROVAL

2006-01-27

LATEST ACTION

2018-04-25

ROUTE

INHALATION

DOSAGE FORM

AEROSOL, METERED

MARKETING STATUS

Discontinued

Products

AEROSPAN HFA · ReferenceDiscontinued

FLUNISOLIDE 0.078MG/INH · AEROSOL, METERED · INHALATION

2018-04-25Labeling · Supplement 17 · standard — Label ↗AP

2017-11-17Labeling · Supplement 16 · standard — Label ↗AP

2017-06-23Labeling · Supplement 15 · standard — Label ↗AP

2016-04-22Manufacturing (CMC) · Supplement 14 · standardAP

2016-03-09Manufacturing (CMC) · Supplement 13 · standardAP

2015-02-09Manufacturing (CMC) · Supplement 12 · standardAP

2014-02-14Manufacturing (CMC) · Supplement 11 · standardAP

2013-12-09Manufacturing (CMC) · Supplement 10 · standardAP

2013-09-30Manufacturing (CMC) · Supplement 9 · standardAP

2013-08-28Efficacy · Supplement 8 · standard — Letter ↗AP

2012-11-16Labeling · Supplement 7 · standard — Label ↗AP

2006-01-27Type 3 - New Dosage Form · Original · standard — Review ↗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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