APPLICATION
ANDA077224
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-28
LATEST ACTION
2021-04-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
RIBAVIRINPrescription
RIBAVIRIN 200MG · CAPSULE · ORAL
Approval history
2021-04-13Labeling · Supplement 21 · standardAP
2021-04-13Labeling · Supplement 22 · standardAP
2021-04-13Labeling · Supplement 19 · standardAP
2016-01-11Labeling · Supplement 16 · standardAP
2015-03-02Labeling · Supplement 13 · standardAP
2015-03-02Labeling · Supplement 14 · standardAP
2011-10-06REMS · Supplement 11AP
2011-03-18Labeling · Supplement 9AP
2011-03-18REMS · Supplement 10AP
2008-04-11Labeling · Supplement 7AP
2008-02-14Labeling · Supplement 6AP
2007-02-27Labeling · Supplement 5AP
2007-01-03Labeling · Supplement 4AP
2006-11-20Labeling · Supplement 2AP
2005-10-28OriginalAP
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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