APPLICATION
NDA018521
TYPE
NDA
ORIGINAL APPROVAL
1981-09-24
LATEST ACTION
2000-08-30
ROUTE
NASAL
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
VANCENASEDiscontinued
BECLOMETHASONE DIPROPIONATE 0.042MG/INH · AEROSOL, METERED · NASAL
Approval history
2000-08-30Manufacturing (CMC) · Supplement 32 · priorityAP
2000-07-26Manufacturing (CMC) · Supplement 31 · priorityAP
1999-03-11Manufacturing (CMC) · Supplement 29 · priorityAP
1997-03-03Labeling · Supplement 25 · priorityAP
1997-02-03Labeling · Supplement 24 · priorityAP
1995-08-03Manufacturing (CMC) · Supplement 26 · priorityAP
1988-12-15Labeling · Supplement 23 · priorityAP
1988-08-04Labeling · Supplement 20 · priorityAP
1988-08-02Manufacturing (CMC) · Supplement 21 · priorityAP
1988-05-09Labeling · Supplement 6 · priorityAP
1988-02-01Manufacturing (CMC) · Supplement 18 · priorityAP
1987-09-24Manufacturing (CMC) · Supplement 19 · priorityAP
1986-07-08Manufacturing (CMC) · Supplement 17 · priorityAP
1986-03-06Manufacturing (CMC) · Supplement 16 · priorityAP
1986-02-24Manufacturing (CMC) · Supplement 14 · priorityAP
1986-02-24Labeling · Supplement 15 · priorityAP
1985-11-02Labeling · Supplement 13 · priorityAP
1985-11-02Efficacy · Supplement 11 · priorityAP
1985-02-21Manufacturing (CMC) · Supplement 10 · priorityAP
1985-01-02Manufacturing (CMC) · Supplement 12 · priorityAP
1984-12-17Manufacturing (CMC) · Supplement 7 · priorityAP
1982-02-04Manufacturing (CMC) · Supplement 4 · priorityAP
1982-02-04Manufacturing (CMC) · Supplement 5 · priorityAP
1981-12-03Manufacturing (CMC) · Supplement 3 · priorityAP
1981-11-06Labeling · Supplement 2 · priorityAP
1981-11-06Manufacturing (CMC) · Supplement 1 · priorityAP
1981-09-24Type 3 - New Dosage Form · Original · priorityAP
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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