APPLICATION
ANDA076192
TYPE
ANDA
ORIGINAL APPROVAL
2004-04-06
LATEST ACTION
2016-01-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
RIBAVIRINDiscontinued
RIBAVIRIN 200MG · CAPSULE · ORAL
Approval history
2016-01-11Labeling · Supplement 20 · standardAP
2014-07-08Labeling · Supplement 17 · standardAP
2014-07-08Labeling · Supplement 18 · standardAP
2014-07-08Labeling · Supplement 16 · standardAP
2011-08-01Labeling · Supplement 15AP
2008-07-21Labeling · Supplement 12AP
2008-01-04Labeling · Supplement 11AP
2006-03-28Labeling · Supplement 3AP
2004-09-15Labeling · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.