APPLICATION
NDA020014
TYPE
NDA
ORIGINAL APPROVAL
1992-11-30
LATEST ACTION
2006-07-27
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
MAXAIRDiscontinued
PIRBUTEROL ACETATE EQ 0.2MG BASE/INH · AEROSOL, METERED · INHALATION
Approval history
2001-11-27Manufacturing (CMC) · Supplement 16 · standardAP
2001-05-11Manufacturing (CMC) · Supplement 14 · standardAP
2001-04-17Manufacturing (CMC) · Supplement 15 · standardAP
2000-11-29Manufacturing (CMC) · Supplement 13 · standardAP
2000-05-26Manufacturing (CMC) · Supplement 12 · standardAP
2000-05-26Manufacturing (CMC) · Supplement 11 · standardAP
1998-11-12Manufacturing (CMC) · Supplement 10 · standardAP
1998-02-11Labeling · Supplement 9 · standardAP
1997-07-24Labeling · Supplement 8 · standardAP
1996-07-29Manufacturing (CMC) · Supplement 6 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 4 · standardAP
1994-10-07Labeling · Supplement 5 · standardAP
1994-02-25Manufacturing (CMC) · Supplement 1 · standardAP
1993-12-06Labeling · Supplement 3 · standardAP
1992-11-30Type 3 - New Dosage Form · Original · standardAP
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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