APPLICATION
NDA018596
TYPE
NDA
ORIGINAL APPROVAL
1982-05-28
LATEST ACTION
2004-02-11
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
INTAL · ReferenceDiscontinued
CROMOLYN SODIUM 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION
Approval history
2002-03-06Manufacturing (CMC) · Supplement 28 · priorityAP
2002-03-06Manufacturing (CMC) · Supplement 27 · priorityAP
1997-05-27Labeling · Supplement 26 · standardAP
1996-03-18Labeling · Supplement 21 · standardAP
1996-02-26Manufacturing (CMC) · Supplement 25 · priorityAP
1995-12-18Manufacturing (CMC) · Supplement 23 · priorityAP
1993-08-09Labeling · Supplement 20 · standardAP
1993-03-18Manufacturing (CMC) · Supplement 14 · priorityAP
1993-03-18Manufacturing (CMC) · Supplement 13 · priorityAP
1988-04-15Manufacturing (CMC) · Supplement 15 · priorityAP
1986-11-28Manufacturing (CMC) · Supplement 12 · priorityAP
1986-08-29Manufacturing (CMC) · Supplement 10 · priorityAP
1986-02-05Manufacturing (CMC) · Supplement 8 · priorityAP
1986-02-05Manufacturing (CMC) · Supplement 9 · priorityAP
1985-01-19Labeling · Supplement 6AP
1984-11-30Manufacturing (CMC) · Supplement 7 · priorityAP
1984-09-20Labeling · Supplement 4AP
1984-08-31Manufacturing (CMC) · Supplement 5 · priorityAP
1983-10-11Labeling · Supplement 1AP
1982-12-27Labeling · Supplement 2AP
1982-12-27Manufacturing (CMC) · Supplement 3 · priorityAP
1982-05-28Type 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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