Boniva

NDA 21858, held by Roche. Ibandronate Sodium.

As of Nov 14, 2026, NDA 21858 (Boniva), held by Roche, was first approved by FDA on Jan 6, 2006, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 6, 2006
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jan 6, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
BonivaEQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;intravenous	Ibandronate Sodium	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Jan 11, 2022	Supplement 23Labeling · Standard review	Approved	Label Letter
Dec 7, 2016	Supplement 22Labeling · Standard review	Approved	Medication Guide Label Letter
Jul 22, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
May 4, 2015	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 8, 2015	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 18, 2015	Supplement 19Labeling · Standard review	Approved	Letter Label
Oct 20, 2014	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 8, 2014	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 18, 2014	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 19, 2013	Supplement 14Labeling · Standard review	Approved	Letter Label
Apr 19, 2013	Supplement 13Labeling · Standard review	Approved	Letter Label
Apr 19, 2013	Supplement 8Labeling · Standard review	Approved	Letter Label
Aug 10, 2011	Supplement 10Labeling	Approved	Letter
Jul 1, 2011	Supplement 12REMS	Approved	Letter
Jan 25, 2011	Supplement 9REMS	Approved	Letter Label
Feb 12, 2007	Supplement 4Labeling · Standard review	Approved	Letter
Aug 7, 2006	Supplement 1Labeling · Standard review	Approved	Letter Label
Jan 6, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21858
Drugs@FDA: Overview at FDA
Company: Roche

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters