APPLICATION
NDA018859
TYPE
NDA
ORIGINAL APPROVAL
1985-12-31
LATEST ACTION
2016-01-06
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
VIRAZOLE · ReferenceDiscontinued
RIBAVIRIN 6GM/VIAL · FOR SOLUTION · INHALATION
Approval history
2016-01-06Manufacturing (CMC) · Supplement 32 · priorityAP
2014-06-27Manufacturing (CMC) · Supplement 31 · priorityAP
2000-02-28Manufacturing (CMC) · Supplement 26 · priorityAP
1998-03-26Manufacturing (CMC) · Supplement 25 · priorityAP
1994-09-26Labeling · Supplement 24 · standardAP
1994-03-10Manufacturing (CMC) · Supplement 23 · priorityAP
1993-07-12Manufacturing (CMC) · Supplement 21 · priorityAP
1993-04-01Labeling · Supplement 22 · standardAP
1993-03-04Manufacturing (CMC) · Supplement 16 · priorityAP
1993-02-05Efficacy · Supplement 3AP
1992-09-23Manufacturing (CMC) · Supplement 13 · priorityAP
1990-06-06Labeling · Supplement 17AP
1989-06-02Manufacturing (CMC) · Supplement 6 · priorityAP
1989-03-28Manufacturing (CMC) · Supplement 12 · priorityAP
1989-03-13Manufacturing (CMC) · Supplement 14 · priorityAP
1989-03-13Manufacturing (CMC) · Supplement 15 · priorityAP
1988-09-15Manufacturing (CMC) · Supplement 8 · priorityAP
1987-04-09Manufacturing (CMC) · Supplement 5 · priorityAP
1986-08-27Manufacturing (CMC) · Supplement 2 · priorityAP
1986-08-27Manufacturing (CMC) · Supplement 1 · 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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