NDA 022154

NOVARTIS

FDA Drug Application

Application #022154

Documents

• Letter: 2009-05-06
• Letter: 2010-03-08
• Label: 2010-03-09
• Label: 2010-10-04
• Label: 2011-04-01
• Label: 2013-02-12
• Review: 2009-11-10
• Letter: 2010-09-16
• Letter: 2011-04-01
• Letter: 2011-05-10
• Letter: 2012-01-03
• Letter: 2013-01-30
• Label: 2009-05-11
• Label: 2011-12-23
• Summary Review: 2009-11-10
• Letter: 2018-03-29
• Label: 2018-04-01
• Label: 2018-12-28
• Medication Guide: 2018-12-28
• Letter: 2018-12-30

Application Sponsors

NDA 022154

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

100MG/5ML

0

TYZEKA

TELBIVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2009-04-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2010-09-10	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	2011-03-29	901 REQUIRED
REMS; REMS	SUPPL	8	AP	2011-05-05	N/A
LABELING; Labeling	SUPPL	9	AP	2011-12-23	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2013-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2013-12-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2014-01-30	STANDARD
LABELING; Labeling	SUPPL	18	AP	2018-03-28	STANDARD
LABELING; Labeling	SUPPL	19	AP	2018-12-27	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	7
SUPPL	6	Null	6
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	6
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	6
SUPPL	19	Null	6

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22154
            [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":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/27\/2018","submission":"SUPPL-19","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-18","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-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022011s013,022154s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2011","submission":"SUPPL-9","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-6","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-3","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-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022011s003,022154s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022154lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TYZEKA","submission":"TELBIVUDINE","actionType":"100MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2018-12-27
        )

)