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FDA NDA · NDA021455

BONIVA

Sponsor: HOFFMANN LA ROCHE

APPLICATION
NDA021455
TYPE
NDA
ORIGINAL APPROVAL
2003-05-16
LATEST ACTION
2016-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BONIVA · ReferenceDiscontinued
IBANDRONATE SODIUM EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
BONIVA · ReferenceDiscontinued
IBANDRONATE SODIUM EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2016-12-07Labeling · Supplement 21 · standard — Label ↗AP
2015-04-08Labeling · Supplement 20 · standard — Letter ↗AP
2015-03-18Labeling · Supplement 19 · standard — Label ↗AP
2014-12-17Labeling · Supplement 18 · standard — Letter ↗AP
2014-06-18Manufacturing (CMC) · Supplement 17 · standardAP
2013-04-19Labeling · Supplement 14 · standard — Letter ↗AP
2013-04-19Labeling · Supplement 15 · standard — Letter ↗AP
2013-04-05Manufacturing (CMC) · Supplement 16 · standardAP
2011-07-01REMS · Supplement 13 — Letter ↗AP
2011-01-25REMS · Supplement 11 — Label ↗AP
2010-01-08Labeling · Supplement 9 · standard — Letter ↗AP
2008-11-28Efficacy · Supplement 7 · unknown — Review ↗AP
2007-02-13Labeling · Supplement 5 · standard — Label ↗AP
2006-06-14Labeling · Supplement 3 · standard — Letter ↗AP
2005-03-24Efficacy · Supplement 1 · unknown — Letter ↗AP
2003-05-16Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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