APPLICATION
ANDA079117
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-17
LATEST ACTION
2023-03-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
RIBAVIRINPrescription
RIBAVIRIN 200MG · CAPSULE · ORAL
Approval history
2023-03-22Labeling · Supplement 18 · standardAP
2021-04-14Labeling · Supplement 16 · standardAP
2021-04-14Labeling · Supplement 17 · standardAP
2021-04-14Labeling · Supplement 13 · standardAP
2016-01-11Labeling · Supplement 12 · standardAP
2014-05-19Labeling · Supplement 8 · standardAP
2014-05-19Labeling · Supplement 9 · standardAP
2014-05-19Labeling · Supplement 7 · standardAP
2011-11-16Labeling · Supplement 3AP
2010-04-02Labeling · Supplement 1AP
2009-09-17OriginalAP
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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