NDA 021004

GLAXOSMITHKLINE

FDA Drug Application

Application #021004

Documents

• Letter: 1998-12-08
• Letter: 2001-08-16
• Letter: 2004-12-02
• Letter: 2004-09-29
• Letter: 2007-10-04
• Label: 2004-12-03
• Label: 2011-01-24
• Review: 2001-08-16
• Letter: 2003-11-25
• Letter: 2011-01-27
• Letter: 2013-12-24
• Label: 1998-12-08
• Label: 2001-08-16
• Label: 2003-12-01
• Label: 2004-09-29
• Label: 2007-10-04
• Label: 2013-12-23
• Review: 1998-12-08
• Label: 2017-05-09
• Letter: 2017-05-10
• Label: 2017-09-28
• Letter: 2017-09-29
• Label: 2018-11-23
• Letter: 2018-12-07
• Letter: 2021-12-27
• Label: 2021-12-27

Application Sponsors

NDA 021004

GLAXOSMITHKLINE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/ML

1

EPIVIR-HBV

LAMIVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-12-08	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2001-08-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-09-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-12-24	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2003-11-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	2004-11-22	STANDARD
LABELING; Labeling	SUPPL	7	AP	2004-09-27	STANDARD
LABELING; Labeling	SUPPL	10	AP	2007-09-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	2011-01-21	901 REQUIRED
LABELING; Labeling	SUPPL	15	AP	2013-12-20	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-05-08	STANDARD
LABELING; Labeling	SUPPL	17	AP	2017-09-27	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2018-11-15	STANDARD
LABELING; Labeling	SUPPL	23	AP	2021-12-22	STANDARD

Submissions Property Types

SUPPL	2	Null	6
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	9
SUPPL	13	Null	7
SUPPL	15	Null	6
SUPPL	16	Null	33
SUPPL	17	Null	7
SUPPL	20	Null	6
SUPPL	23	Null	15

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21004
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPIVIR-HBV","activeIngredients":"LAMIVUDINE","strength":"5MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/15\/2018","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021004s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021003s017,021004s017lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021003s017,021004s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021003s016,021004s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021003s015,021004s015lbl.pdf\"}]","notes":""},{"actionDate":"01\/21\/2011","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021003s013,021004s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2007","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021003s010,021004s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2004","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21003s005,21004s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2004","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21003s006,21004s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2003","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21003slr004,21004slr005_epivir_lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2001","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21004s2lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/98\\\/21003_Epivir-HBV_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EPIVIR-HBV","submission":"LAMIVUDINE","actionType":"5MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-11-15
        )

)