← FDA DRUG APPROVALS

FDA NDA · NDA020503

ALBUTEROL SULFATE

Sponsor: KINDEVA

APPLICATION
NDA020503
TYPE
NDA
ORIGINAL APPROVAL
1996-08-15
LATEST ACTION
2017-09-22
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

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

Approval history

2017-09-22Labeling · Supplement 54 · standard — Letter ↗AP
2016-11-09Manufacturing (CMC) · Supplement 53 · standardAP
2016-03-03Manufacturing (CMC) · Supplement 51 · standardAP
2016-02-12Manufacturing (CMC) · Supplement 50 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 49 · standardAP
2013-02-25Manufacturing (CMC) · Supplement 47 · standard — Review ↗AP
2012-06-05Labeling · Supplement 46 · unknown — Letter ↗AP
2009-09-08Labeling · Supplement 39 · standard — Letter ↗AP
2004-01-29Labeling · Supplement 22 · standard — Letter ↗AP
2002-07-26Manufacturing (CMC) · Supplement 21 · standardAP
2002-01-18Manufacturing (CMC) · Supplement 15 · standardAP
2002-01-17Manufacturing (CMC) · Supplement 20 · standardAP
2002-01-10Manufacturing (CMC) · Supplement 18 · standardAP
2001-04-17Manufacturing (CMC) · Supplement 19 · standardAP
2000-10-05Manufacturing (CMC) · Supplement 17 · standardAP
2000-09-28Manufacturing (CMC) · Supplement 16 · standardAP
2000-06-16Manufacturing (CMC) · Supplement 14 · standardAP
2000-06-16Manufacturing (CMC) · Supplement 6 · standardAP
2000-04-12Manufacturing (CMC) · Supplement 12 · standardAP
2000-04-04Manufacturing (CMC) · Supplement 9 · standardAP
2000-03-13Manufacturing (CMC) · Supplement 13 · standardAP
1999-08-18Manufacturing (CMC) · Supplement 10 · standardAP
1999-06-17Manufacturing (CMC) · Supplement 8 · standardAP
1999-06-02Efficacy · Supplement 11 · standard — Review ↗AP
1998-09-23Efficacy · Supplement 4 · standard — Label ↗AP
1998-03-12Manufacturing (CMC) · Supplement 7 · standardAP
1998-02-05Manufacturing (CMC) · Supplement 5 · standardAP
1997-08-18Manufacturing (CMC) · Supplement 3 · standardAP
1997-04-22Labeling · Supplement 2 · standardAP
1996-12-26Manufacturing (CMC) · Supplement 1 · standardAP
1996-08-15Type 3 - New Dosage Form · Original · standardAP
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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