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FDA NDA · NDA021457

ALBUTEROL SULFATE HFA

albuterol sulfate

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA021457
TYPE
NDA
ORIGINAL APPROVAL
2004-10-29
LATEST ACTION
2019-02-25
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

PROAIR HFA · ReferencePrescription
ALBUTEROL SULFATE EQ 0.09MG BASE/INH · AEROSOL, METERED · INHALATION

Approval history

2019-02-25Labeling · Supplement 36 · standard — Letter ↗AP
2016-05-20Manufacturing (CMC) · Supplement 31 · standardAP
2014-01-08Manufacturing (CMC) · Supplement 30 · standardAP
2013-03-23Manufacturing (CMC) · Supplement 29 · standardAP
2013-01-09Manufacturing (CMC) · Supplement 28 · standardAP
2012-12-10Manufacturing (CMC) · Supplement 27 · standardAP
2012-03-07Manufacturing (CMC) · Supplement 26 · standard — Label ↗AP
2010-12-10Manufacturing (CMC) · Supplement 23 · standardAP
2010-12-08Labeling · Supplement 22 · unknown — Letter ↗AP
2010-08-17Labeling · Supplement 21 · standard — Letter ↗AP
2008-09-16Efficacy · Supplement 13 · unknown — Letter ↗AP
2006-02-03Efficacy · Supplement 3 · unknown — Label ↗AP
2005-11-21Labeling · Supplement 2 · standard — Label ↗AP
2005-11-21Labeling · Supplement 4 · standard — Label ↗AP
2005-05-02Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2004-10-29Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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