APPLICATION
ANDA077743
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-03
LATEST ACTION
2016-01-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RIBAVIRINPrescription
RIBAVIRIN 200MG · TABLET · ORAL
Approval history
2016-01-09Labeling · Supplement 9 · standardAP
2016-01-09Labeling · Supplement 7 · standardAP
2011-11-30Labeling · Supplement 6AP
2008-08-27Labeling · Supplement 4AP
2008-03-20Manufacturing (CMC) · Supplement 1AP
2008-03-05Labeling · Supplement 3AP
2006-10-03OriginalAP
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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