APPLICATION
ANDA077053
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-05
LATEST ACTION
2023-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RIBAVIRINDiscontinued
RIBAVIRIN 200MG · TABLET · ORAL
Approval history
2023-05-08Labeling · Supplement 14 · standardAP
2013-04-30Labeling · Supplement 13 · standardAP
2011-03-18Labeling · Supplement 12AP
2011-01-12REMS · Supplement 10AP
2011-01-10Labeling · Supplement 11AP
2010-09-08Labeling · Supplement 9AP
2010-05-11Labeling · Supplement 8AP
2010-03-08Labeling · Supplement 7AP
2009-01-14Labeling · Supplement 6AP
2008-06-30Labeling · Supplement 5AP
2008-03-07Labeling · Supplement 4AP
2006-04-10Labeling · Supplement 1AP
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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