ACTONEL · ReferenceDiscontinued
RISEDRONATE SODIUM 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ACTONEL · ReferenceDiscontinued
RISEDRONATE SODIUM 5MG · TABLET · ORAL
ACTONEL · ReferencePrescription
RISEDRONATE SODIUM 150MG · TABLET · ORAL
ACTONEL · ReferencePrescription
RISEDRONATE SODIUM 35MG · TABLET · ORAL
ACTONEL · ReferenceDiscontinued
RISEDRONATE SODIUM 30MG · TABLET · ORAL
2026-02-03Labeling · Supplement 54 · standard — Letter ↗AP 2019-11-05Labeling · Supplement 52 · standard — Letter ↗AP 2015-10-22Manufacturing (CMC) · Supplement 49AP
2015-04-08Labeling · Supplement 48 · standard — Letter ↗AP 2015-03-26Labeling · Supplement 47 · standard — Label ↗AP 2014-12-02Manufacturing (CMC) · Supplement 46AP
2013-04-19Labeling · Supplement 45 · standard — Letter ↗AP 2011-08-22REMS · Supplement 44 — Letter ↗AP 2011-01-25REMS · Supplement 43 — Label ↗AP 2011-01-25Labeling · Supplement 42 · standard — Letter ↗AP 2009-12-31Labeling · Supplement 36 · standard — Label ↗AP 2008-04-22Efficacy · Supplement 30 · unknown — Letter ↗AP 2008-04-22Labeling · Supplement 29 · standard — Letter ↗AP 2007-07-24Labeling · Supplement 28 · standard — Letter ↗AP 2007-04-16Efficacy · Supplement 25 · unknown — Label ↗AP 2006-08-11Efficacy · Supplement 22 · unknown — Label ↗AP 2006-08-11Labeling · Supplement 23 · standard — Letter ↗AP 2006-01-24Efficacy · Supplement 19 · unknown — Letter ↗AP 2005-09-12Labeling · Supplement 20 · standard — Label ↗AP 2005-05-06Labeling · Supplement 18 · standard — Letter ↗AP 2004-02-24Labeling · Supplement 14 · standard — Review ↗AP 2002-12-10Manufacturing (CMC) · Supplement 12 — Review ↗AP 2002-11-05Manufacturing (CMC) · Supplement 11 — Review ↗AP 2002-09-26Manufacturing (CMC) · Supplement 10 — Review ↗AP 2002-05-17Efficacy · Supplement 8 · standard — Letter ↗AP 2002-05-17Efficacy · Supplement 9 · standard — Letter ↗AP 2001-12-21Manufacturing (CMC) · Supplement 7AP
2001-05-02Manufacturing (CMC) · Supplement 5AP
2000-04-14Efficacy · Supplement 4 · priority — Letter ↗AP 2000-04-14Efficacy · Supplement 2 · unknown — Review ↗AP 2000-04-14Efficacy · Supplement 3 · unknown — Review ↗AP 2000-04-14Efficacy · Supplement 1 · priority — Letter ↗AP 1998-03-27Type 1 - New Molecular Entity · Original · standard — Letter ↗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.