APPLICATION
ANDA076203
TYPE
ANDA
ORIGINAL APPROVAL
2004-04-06
LATEST ACTION
2014-05-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
RIBASPHEREDiscontinued
RIBAVIRIN 200MG · CAPSULE · ORAL
Approval history
2014-05-31Labeling · Supplement 18 · standardAP
2013-03-18REMS · Supplement 16AP
2011-02-28Labeling · Supplement 15AP
2008-08-25Labeling · Supplement 14AP
2008-04-14Labeling · Supplement 13AP
2007-01-09Labeling · Supplement 11AP
2005-07-08Labeling · Supplement 8AP
2005-02-10Labeling · Supplement 7AP
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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