REBETOLDiscontinued
RIBAVIRIN 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy** · CAPSULE · ORAL
REBETOL · ReferenceDiscontinued
RIBAVIRIN 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
2022-03-16Labeling · Supplement 57 · standard — Letter ↗AP 2020-01-28Labeling · Supplement 56 · standard — Letter ↗AP 2019-05-02Labeling · Supplement 55 · standard — Label ↗AP 2015-05-21Labeling · Supplement 53 · standard — Label ↗AP 2013-11-15Labeling · Supplement 52 · standard — Label ↗AP 2013-05-31Labeling · Supplement 51 · standard — Letter ↗AP 2013-02-06Labeling · Supplement 50 · 901 required — Letter ↗AP 2013-01-04Manufacturing (CMC) · Supplement 49 · priorityAP
2011-05-06REMS · Supplement 48 — Letter ↗AP 2010-10-28Labeling · Supplement 46 · unknown — Label ↗AP 2009-11-06Labeling · Supplement 45 · standard — Letter ↗AP 2009-11-06Labeling · Supplement 43 · standard — Letter ↗AP 2009-11-06Labeling · Supplement 44 · standard — Letter ↗AP 2009-11-06Labeling · Supplement 42 · standard — Label ↗AP 2007-12-04Labeling · Supplement 40 · standard — Label ↗AP 2007-04-13Labeling · Supplement 39 · standard — Letter ↗AP 2006-08-25Labeling · Supplement 38 · standard — Label ↗AP 2004-06-24Labeling · Supplement 34 · standard — Label ↗AP 2004-06-08Labeling · Supplement 33 · standard — Label ↗AP 2003-10-10Labeling · Supplement 32 · standard — Label ↗AP 2003-07-09Labeling · Supplement 30 · standard — Letter ↗AP 2003-06-09Labeling · Supplement 28 · standard — Letter ↗AP 2003-05-21Labeling · Supplement 29 · standard — Label ↗AP 2002-12-20Manufacturing (CMC) · Supplement 27 · priorityAP
2002-11-13Labeling · Supplement 25 · standard — Letter ↗AP 2002-11-13Labeling · Supplement 24 · standardAP
2002-09-03Labeling · Supplement 23 · standard — Label ↗AP 2002-03-06Efficacy · Supplement 20 · unknown — Review ↗AP 2002-02-21Labeling · Supplement 15 · standard — Letter ↗AP 2002-01-03Manufacturing (CMC) · Supplement 21 · priorityAP
2001-12-28Efficacy · Supplement 13 · standard — Letter ↗AP 2001-11-05Manufacturing (CMC) · Supplement 17 · priorityAP
2001-10-31Labeling · Supplement 10 · standard — Label ↗AP 2001-10-24Labeling · Supplement 14 · standard — Label ↗AP 2001-08-29Manufacturing (CMC) · Supplement 19 · priorityAP
2001-07-25Labeling · Supplement 11 · standard — Label ↗AP 2001-07-25Labeling · Supplement 8 · standard — Review ↗AP 2001-07-25Labeling · Supplement 16 · standard — Letter ↗AP 2001-07-25Labeling · Supplement 12 · standard — Review ↗AP 2001-03-13Labeling · Supplement 7 · standard — Review ↗AP 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.