APPLICATION
NDA019660
TYPE
NDA
ORIGINAL APPROVAL
1992-12-30
LATEST ACTION
2004-02-11
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
TILADEDiscontinued
NEDOCROMIL SODIUM 1.75MG/INH · AEROSOL, METERED · INHALATION
Approval history
1998-01-30Labeling · Supplement 16 · standardAP
1997-03-06Efficacy · Supplement 15 · standardAP
1996-02-26Manufacturing (CMC) · Supplement 14 · standardAP
1996-01-04Labeling · Supplement 11 · standardAP
1995-12-27Manufacturing (CMC) · Supplement 6 · standardAP
1995-12-27Manufacturing (CMC) · Supplement 7 · standardAP
1995-09-20Manufacturing (CMC) · Supplement 13 · standardAP
1995-08-07Manufacturing (CMC) · Supplement 12 · standardAP
1995-04-20Manufacturing (CMC) · Supplement 10 · standardAP
1994-12-01Manufacturing (CMC) · Supplement 9 · standardAP
1994-08-16Manufacturing (CMC) · Supplement 8 · standardAP
1994-05-03Manufacturing (CMC) · Supplement 5 · standardAP
1994-02-28Manufacturing (CMC) · Supplement 4 · standardAP
1993-05-19Manufacturing (CMC) · Supplement 3 · standardAP
1993-05-18Efficacy · Supplement 1 · unknownAP
1992-12-30Type 1 - New Molecular Entity · 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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