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FDA NDA · NDA021858

BONIVA

Sponsor: ROCHE

APPLICATION
NDA021858
TYPE
NDA
ORIGINAL APPROVAL
2006-01-06
LATEST ACTION
2022-01-11
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

BONIVA · ReferenceDiscontinued
IBANDRONATE SODIUM EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2022-01-11Labeling · Supplement 23 · standard — Label ↗AP
2016-12-07Labeling · Supplement 22 · standard — Letter ↗AP
2015-07-22Manufacturing (CMC) · Supplement 21 · standardAP
2015-05-04Manufacturing (CMC) · Supplement 18 · standardAP
2015-04-08Labeling · Supplement 20 · standard — Letter ↗AP
2015-03-18Labeling · Supplement 19 · standard — Label ↗AP
2014-10-20Manufacturing (CMC) · Supplement 16 · standardAP
2014-09-08Manufacturing (CMC) · Supplement 17 · standardAP
2014-06-18Manufacturing (CMC) · Supplement 15 · standardAP
2013-04-19Labeling · Supplement 14 · standard — Letter ↗AP
2013-04-19Labeling · Supplement 8 · standard — Letter ↗AP
2013-04-19Labeling · Supplement 13 · standard — Label ↗AP
2011-08-10Labeling · Supplement 10 · unknown — Letter ↗AP
2011-07-01REMS · Supplement 12 — Letter ↗AP
2011-01-25REMS · Supplement 9 — Label ↗AP
2007-02-12Labeling · Supplement 4 · standard — Letter ↗AP
2006-08-07Labeling · Supplement 1 · standard — Letter ↗AP
2006-01-06Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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