← FDA DRUG APPROVALS

FDA NDA · NDA020983

VENTOLIN HFA

albuterol sulfate

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020983
TYPE
NDA
ORIGINAL APPROVAL
2001-04-19
LATEST ACTION
2021-08-18
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

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

Approval history

2021-08-18Labeling · Supplement 41 · standard — Letter ↗AP
2019-12-16Labeling · Supplement 36 · standard — Label ↗AP
2015-08-14Manufacturing (CMC) · Supplement 34 · standardAP
2015-01-12Manufacturing (CMC) · Supplement 33 · standardAP
2014-12-19Labeling · Supplement 32 · standard — Letter ↗AP
2014-06-17Manufacturing (CMC) · Supplement 31 · standardAP
2014-01-21Manufacturing (CMC) · Supplement 29 · standardAP
2014-01-03Manufacturing (CMC) · Supplement 30 · standardAP
2012-09-06Labeling · Supplement 27 · unknown — Label ↗AP
2008-08-27UNKNOWN · Supplement 13 · unknown — Pediatric Written Request ↗AP
2008-03-26Efficacy · Supplement 16 · priority — Label ↗AP
2006-03-17Manufacturing (CMC) · Supplement 10AP
2005-04-19Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
2002-09-10Manufacturing (CMC) · Supplement 5 · standardAP
2002-03-04Manufacturing (CMC) · Supplement 3 · standardAP
2001-10-25Manufacturing (CMC) · Supplement 2 · standardAP
2001-07-09Manufacturing (CMC) · Supplement 1 · standardAP
2001-04-19Type 3 - New Dosage Form · Original · standard — Letter ↗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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