NDA 021858

ROCHE

FDA Drug Application

Application #021858

Documents

• Letter: 2006-01-10
• Letter: 2006-08-09
• Letter: 2007-02-23
• Letter: 2013-04-24
• Letter: 2015-03-19
• Letter: 2015-04-13
• Label: 2006-01-10
• Label: 2006-08-09
• Label: 2011-01-26
• Label: 2013-04-23
• Review: 2007-05-09
• Letter: 2013-04-24
• Letter: 2011-01-27
• Letter: 2011-08-12
• Letter: 2011-07-07
• Letter: 2013-04-24
• Label: 2013-04-23
• Label: 2013-04-23
• Label: 2015-03-19
• Label: 2015-04-10
• Other Important Information from FDA: 2008-01-07
• Letter: 2016-12-09
• Label: 2016-12-13
• Medication Guide: 2017-01-03
• Label: 2022-01-12
• Letter: 2022-01-12

Application Sponsors

NDA 021858

ROCHE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 3MG BASE/3ML

1

BONIVA

IBANDRONATE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2006-01-06	STANDARD
LABELING; Labeling	SUPPL	4	AP	2007-02-12	STANDARD
LABELING; Labeling	SUPPL	8	AP	2013-04-19	STANDARD
REMS; REMS	SUPPL	9	AP	2011-01-25	N/A
LABELING; Labeling	SUPPL	10	AP	2011-08-10	UNKNOWN
REMS; REMS	SUPPL	12	AP	2011-07-01	N/A
LABELING; Labeling	SUPPL	13	AP	2013-04-19	STANDARD
LABELING; Labeling	SUPPL	14	AP	2013-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2014-06-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2014-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2014-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2015-05-04	STANDARD
LABELING; Labeling	SUPPL	19	AP	2015-03-18	STANDARD
LABELING; Labeling	SUPPL	20	AP	2015-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2015-07-22	STANDARD
LABELING; Labeling	SUPPL	22	AP	2016-12-07	STANDARD
LABELING; Labeling	SUPPL	23	AP	2022-01-11	STANDARD

Submissions Property Types

SUPPL	8	Null	6
SUPPL	9	Null	6
SUPPL	10	Null	6
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	6
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	15
SUPPL	20	Null	6
SUPPL	21	Null	0
SUPPL	22	Null	6
SUPPL	23	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21858
            [companyName] => ROCHE
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/021858s022lbl.pdf#page=18"]
            [products] => [{"drugName":"BONIVA","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 3MG BASE\/3ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/07\/2016","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021858s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021858s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021858s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021858s008s013s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021858s008s013s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021858s008s013s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2011","submission":"SUPPL-9","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021858s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2006","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021858s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/06\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021858s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BONIVA","submission":"IBANDRONATE SODIUM","actionType":"EQ 3MG BASE\/3ML","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-12-07
        )

)