APPLICATION
NDA020486
TYPE
NDA
ORIGINAL APPROVAL
1996-12-24
LATEST ACTION
2007-12-07
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
VANCERIL DOUBLE STRENGTHDiscontinued
BECLOMETHASONE DIPROPIONATE 0.084MG/INH · AEROSOL, METERED · INHALATION
Approval history
2007-12-07Labeling · Supplement 5 · standardAP
2000-08-30Manufacturing (CMC) · Supplement 9 · standardAP
2000-07-26Manufacturing (CMC) · Supplement 8 · standardAP
2000-06-16Manufacturing (CMC) · Supplement 3 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 4 · standardAP
1997-04-21Manufacturing (CMC) · Supplement 1 · standardAP
1996-12-24Type 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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