NDA 019951

VIIV HLTHCARE

FDA Drug Application

Application #019951

Documents

• Letter: 2002-02-21
• Letter: 2004-06-16
• Letter: 2003-08-15
• Letter: 2006-07-13
• Letter: 2006-11-22
• Letter: 2011-11-28
• Label: 2003-06-10
• Label: 2003-08-06
• Label: 2015-01-08
• Letter: 2012-06-05
• Letter: 2014-12-31
• Label: 2003-08-14
• Label: 2006-07-13
• Label: 2011-11-25
• Label: 2012-06-06
• Label: 2017-02-28
• Letter: 2017-03-03
• Label: 2017-04-13
• Letter: 2017-04-14
• Label: 2017-11-29
• Letter: 2017-12-01
• Label: 2018-09-11
• Letter: 2018-09-12
• Letter: 2019-12-20
• Label: 2021-01-19

Application Sponsors

NDA 019951

VIIV HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

1

RETROVIR

ZIDOVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1990-02-02	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	1994-08-08	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1994-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-02-06
LABELING; Labeling	SUPPL	7	AP	1995-07-20	STANDARD
LABELING; Labeling	SUPPL	8	AP	1996-03-22
LABELING; Labeling	SUPPL	9	AP	1996-04-02	STANDARD
LABELING; Labeling	SUPPL	10	AP	1998-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-08-18
LABELING; Labeling	SUPPL	12	AP	1998-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-02-01
LABELING; Labeling	SUPPL	16	AP	2001-09-12	STANDARD
LABELING; Labeling	SUPPL	17	AP	2002-02-21	STANDARD
LABELING; Labeling	SUPPL	18	AP	2003-07-25	STANDARD
LABELING; Labeling	SUPPL	19	AP	2003-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-08-19
LABELING; Labeling	SUPPL	23	AP	2006-07-10	STANDARD
LABELING; Labeling	SUPPL	24	AP	2006-11-15	STANDARD
LABELING; Labeling	SUPPL	29	AP	2011-11-18	901 REQUIRED
LABELING; Labeling	SUPPL	30	AP	2012-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2013-12-19
LABELING; Labeling	SUPPL	32	AP	2014-12-23	STANDARD
LABELING; Labeling	SUPPL	33	AP	2017-02-24	STANDARD
LABELING; Labeling	SUPPL	34	AP	2017-04-10	STANDARD
LABELING; Labeling	SUPPL	35	AP	2017-11-28	STANDARD
LABELING; Labeling	SUPPL	36	AP	2018-09-10	STANDARD
LABELING; Labeling	SUPPL	37	AP	2020-06-19	STANDARD

Submissions Property Types

ORIG	1	Null	39
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	20	Null	0
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	31	Null	0
SUPPL	32	Null	6
SUPPL	33	Null	15
SUPPL	34	Null	6
SUPPL	35	Null	7
SUPPL	36	Null	15
SUPPL	37	Null	15

TE Codes

001

Prescription

AP

CDER Filings

VIIV HLTHCARE

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(
    [0] => Array
        (
            [ApplNo] => 19951
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"RETROVIR","activeIngredients":"ZIDOVUDINE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/10\/2018","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019655s058,019910s045,019951s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2018","submission":"SUPPL-36","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019655s058,019910s045,019951s036lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2017","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019655s057,019910s044,019951s035lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2017","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019655s056,019910s043,019951s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2017","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019655s055,019910s042,019951s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2014","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019910s041lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2012","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019951s030lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019951s029lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2006","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019951s023lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2003","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19951slr019_retrovir_lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2003","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19951slr018_retrovir_lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2001","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19951s16lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RETROVIR","submission":"ZIDOVUDINE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-09-10
        )

)