APPLICATION
NDA019389
TYPE
NDA
ORIGINAL APPROVAL
1987-07-27
LATEST ACTION
2019-04-12
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued
Products
BECONASE AQ · ReferenceDiscontinued
BECLOMETHASONE DIPROPIONATE MONOHYDRATE EQ 0.042MG DIPROP/SPRAY · SPRAY, METERED · NASAL
Approval history
2014-06-17Manufacturing (CMC) · Supplement 33 · standardAP
2002-03-04Manufacturing (CMC) · Supplement 26 · standardAP
2001-07-09Manufacturing (CMC) · Supplement 24 · standardAP
1999-02-24Manufacturing (CMC) · Supplement 20 · standardAP
1998-03-27Manufacturing (CMC) · Supplement 19 · standardAP
1997-05-30Labeling · Supplement 17 · standardAP
1996-11-26Labeling · Supplement 16 · standardAP
1993-11-19Labeling · Supplement 12AP
1992-10-06Manufacturing (CMC) · Supplement 9 · standardAP
1992-08-10Manufacturing (CMC) · Supplement 11 · standardAP
1990-05-15Manufacturing (CMC) · Supplement 7 · standardAP
1989-09-07Manufacturing (CMC) · Supplement 6 · standardAP
1989-08-25Manufacturing (CMC) · Supplement 2 · standardAP
1989-03-09Manufacturing (CMC) · Supplement 5 · standardAP
1988-12-19Labeling · Supplement 4AP
1988-08-19Manufacturing (CMC) · Supplement 1 · standardAP
1988-07-08Manufacturing (CMC) · Supplement 3 · standardAP
1987-07-27Type 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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