APPLICATION
NDA018117
TYPE
NDA
ORIGINAL APPROVAL
1982-04-23
LATEST ACTION
2008-03-13
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
AZMACORTDiscontinued
TRIAMCINOLONE ACETONIDE 0.1MG/INH · AEROSOL, METERED · INHALATION
Approval history
2000-08-17Manufacturing (CMC) · Supplement 31 · standardAP
1997-06-12Manufacturing (CMC) · Supplement 28 · standardAP
1996-11-21Manufacturing (CMC) · Supplement 25 · standardAP
1996-10-30Efficacy · Supplement 26 · standardAP
1996-07-02Manufacturing (CMC) · Supplement 27 · standardAP
1992-11-30Manufacturing (CMC) · Supplement 22 · standardAP
1992-02-18Manufacturing (CMC) · Supplement 20 · standardAP
1992-02-12Manufacturing (CMC) · Supplement 18 · standardAP
1991-05-17Manufacturing (CMC) · Supplement 19 · standardAP
1990-11-01Manufacturing (CMC) · Supplement 15 · standardAP
1990-09-27Manufacturing (CMC) · Supplement 21 · standardAP
1990-05-16Manufacturing (CMC) · Supplement 17 · standardAP
1990-05-15Manufacturing (CMC) · Supplement 14 · standardAP
1989-07-13Manufacturing (CMC) · Supplement 13 · standardAP
1989-07-03Manufacturing (CMC) · Supplement 12 · standardAP
1987-07-23Manufacturing (CMC) · Supplement 10 · standardAP
1985-09-30Manufacturing (CMC) · Supplement 7 · standardAP
1984-11-26Manufacturing (CMC) · Supplement 6 · standardAP
1984-07-31Labeling · Supplement 5AP
1984-03-13Manufacturing (CMC) · Supplement 4 · standardAP
1984-03-13Manufacturing (CMC) · Supplement 3 · standardAP
1984-03-12Labeling · Supplement 2AP
1984-03-12Manufacturing (CMC) · Supplement 1 · standardAP
1982-04-23Type 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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