NDA 022011

NOVARTIS

FDA Drug Application

Application #022011

Documents

• Letter: 2009-05-13
• Letter: 2010-03-08
• Letter: 2010-09-16
• Letter: 2011-05-10
• Letter: 2012-01-03
• Label: 2009-02-04
• Label: 2009-05-13
• Label: 2010-03-09
• Label: 2010-10-04
• Label: 2011-12-23
• Review: 2006-12-22
• Letter: 2006-10-27
• Letter: 2009-01-26
• Letter: 2011-04-01
• Letter: 2013-01-30
• Label: 2006-10-26
• Label: 2011-04-01
• Label: 2013-01-28
• Label: 2013-01-28
• Letter: 2018-03-29
• Label: 2018-04-01
• Label: 2018-12-28
• Medication Guide: 2018-12-28
• Letter: 2018-12-30

Application Sponsors

NDA 022011

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

600MG

1

TYZEKA

TELBIVUDINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2006-10-25	STANDARD
LABELING; Labeling	SUPPL	2	AP	2009-05-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2010-03-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2010-09-10	UNKNOWN
LABELING; Labeling	SUPPL	9	AP	2011-03-29	901 REQUIRED
EFFICACY; Efficacy	SUPPL	10	AP	2013-01-28	STANDARD
REMS; REMS	SUPPL	11	AP	2011-05-05	N/A
LABELING; Labeling	SUPPL	12	AP	2011-12-23	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2013-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2013-12-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	21	AP	2018-03-28	STANDARD
LABELING; Labeling	SUPPL	22	AP	2018-12-27	STANDARD

Submissions Property Types

SUPPL	1	Null	6
SUPPL	3	Null	6
SUPPL	6	Null	7
SUPPL	9	Null	6
SUPPL	10	Null	0
SUPPL	11	Null	6
SUPPL	12	Null	6
SUPPL	13	Null	6
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	15
SUPPL	22	Null	15

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22011
            [companyName] => NOVARTIS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/022011s022,022154s019lbl.pdf#page=19"]
            [products] => [{"drugName":"TYZEKA","activeIngredients":"TELBIVUDINE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/27\/2018","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022011s022,022154s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022011S021_022154_S018lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2013","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022011s013lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2013","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022011s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022011S012,022154S009lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022011s009,022154s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2010","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022011s006,022154s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2010","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022011s003,022154s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022011s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2009","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022011s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2009","submission":"SUPPL-1","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022011s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/022011lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TYZEKA","submission":"TELBIVUDINE","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-27
        )

)