NDA 020564

VIIV HLTHCARE

FDA Drug Application

Application #020564

Documents

• Letter: 2002-03-01
• Letter: 2004-12-02
• Letter: 2006-10-31
• Letter: 2008-02-07
• Letter: 2015-03-26
• Letter: 2015-02-24
• Letter: 2016-07-22
• Label: 2002-10-08
• Label: 2002-06-24
• Label: 2003-12-02
• Label: 2004-12-03
• Review: 2007-09-26
• Letter: 2001-03-06
• Letter: 2002-10-08
• Letter: 2002-06-24
• Letter: 2003-11-25
• Letter: 2004-10-04
• Letter: 2006-06-20
• Letter: 2011-11-22
• Letter: 2015-10-02
• Label: 2004-10-04
• Label: 2006-06-14
• Label: 2006-10-26
• Label: 2008-02-14
• Label: 2011-12-02
• Label: 2015-04-14
• Label: 2015-02-20
• Label: 2015-10-07
• Label: 2016-07-21
• Review: 2007-09-26
• Review: 2005-01-06
• Review: 2007-09-26
• Review: 2007-09-26
• Label: 2017-10-12
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2018-05-01
• Label: 2018-05-07
• Review: 2019-02-15
• Letter: 2019-05-14
• Label: 2019-05-15

Application Sponsors

NDA 020564

VIIV HLTHCARE

Marketing Status

• Prescription: 001
• Prescription: 003

Application Products

001	TABLET;ORAL	150MG	1	EPIVIR	LAMIVUDINE
003	TABLET;ORAL	300MG	1	EPIVIR	LAMIVUDINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1995-11-17	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	1997-04-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-10-31
LABELING; Labeling	SUPPL	4	AP	1997-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-02-03
LABELING; Labeling	SUPPL	6	AP	1997-12-15	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	1999-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-11-05
LABELING; Labeling	SUPPL	9	AP	1999-03-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	1999-03-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2001-01-05	STANDARD
LABELING; Labeling	SUPPL	12	AP	2001-03-06	STANDARD
LABELING; Labeling	SUPPL	13	AP	2001-06-19	STANDARD
LABELING; Labeling	SUPPL	14	AP	2002-10-08	STANDARD
EFFICACY; Efficacy	SUPPL	15	AP	2002-06-24	STANDARD
LABELING; Labeling	SUPPL	16	AP	2002-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-09-13
LABELING; Labeling	SUPPL	19	AP	2003-11-13	STANDARD
TYPE 1; Type 1 - New Molecular Entity	ORIG	20	AP	2004-11-22
LABELING; Labeling	SUPPL	21	AP	2004-09-29	STANDARD
LABELING; Labeling	SUPPL	24	AP	2006-06-13	STANDARD
LABELING; Labeling	SUPPL	26	AP	2006-10-25	STANDARD
EFFICACY; Efficacy	SUPPL	28	AP	2008-02-01	PRIORITY
LABELING; Labeling	SUPPL	31	AP	2011-11-18	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2012-12-18
EFFICACY; Efficacy	SUPPL	33	AP	2015-03-23	STANDARD
LABELING; Labeling	SUPPL	34	AP	2015-02-19	STANDARD
LABELING; Labeling	SUPPL	35	AP	2015-09-30	STANDARD
EFFICACY; Efficacy	SUPPL	36	AP	2016-07-20	PRIORITY
LABELING; Labeling	SUPPL	37	AP	2017-09-25	STANDARD
LABELING; Labeling	SUPPL	38	AP	2018-04-27	STANDARD
LABELING; Labeling	SUPPL	39	AP	2019-05-10	STANDARD

Submissions Property Types

ORIG	1	Null	39
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	17	Null	0
SUPPL	31	Null	15
SUPPL	32	Null	0
SUPPL	33	Null	6
SUPPL	34	Null	6
SUPPL	35	Null	6
SUPPL	36	Null	33
SUPPL	37	Null	7
SUPPL	38	Null	15
SUPPL	39	Null	15

TE Codes

001	Prescription	AB
003	Prescription	AB

CDER Filings

VIIV HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20564
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPIVIR","activeIngredients":"LAMIVUDINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"EPIVIR","activeIngredients":"LAMIVUDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/10\/2019","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020564s039,020596s038lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2019","submission":"SUPPL-39","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020564s039,020596s038lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2018","submission":"SUPPL-38","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020564s038,020596s037lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2018","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020564s035,020596s034lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2015","submission":"SUPPL-33","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020564s033,020596s032lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2015","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020564s034,020596s033lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020564s031,020596s030lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2008","submission":"SUPPL-28","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020564s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2006","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020564s026lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2006","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020596s025,020564s024lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2004","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20596s021,20564s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2004","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20596s022,20564s021lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2003","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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            [originalApprovals] => [{"actionDate":"EPIVIR","submission":"LAMIVUDINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"EPIVIR","submission":"LAMIVUDINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-10
        )

)