Application 019910

Type: NDA
Sponsor: VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RETROVIR	ZIDOVUDINE	SYRUP;ORAL	50MG/5ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49702-212	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-212	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-212	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-212	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-212	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-212	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-212	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-212	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80704	SUPPL	2024-12-23
80650	SUPPL	2024-12-19
65920	SUPPL	2021-01-19
63637	SUPPL	2020-06-19
55436	SUPPL	2018-09-12
55425	SUPPL	2018-09-11
50552	SUPPL	2017-12-01
50527	SUPPL	2017-11-29
48022	SUPPL	2017-04-14
48006	SUPPL	2017-04-13
47439	SUPPL	2017-03-03
47364	SUPPL	2017-02-28
34098	SUPPL	2015-01-08
1809	SUPPL	2014-12-31
34097	SUPPL	2012-06-06
1808	SUPPL	2012-06-04
19841	SUPPL	2011-12-01
34096	SUPPL	2011-11-25
1807	SUPPL	2010-05-21
11849	SUPPL	2010-05-18
1806	SUPPL	2010-01-07
11848	SUPPL	2009-11-19
34095	SUPPL	2008-09-23
1805	SUPPL	2008-09-23
19840	SUPPL	2006-11-22
11847	SUPPL	2006-11-16
1804	SUPPL	2006-05-18
11846	SUPPL	2006-05-16
20422	SUPPL	2005-04-19
11845	SUPPL	2003-10-17
1803	SUPPL	2003-10-17
11844	SUPPL	2003-06-10
34094	SUPPL	2003-04-04
19839	SUPPL	2002-12-18
19838	SUPPL	2002-02-21
34093	SUPPL	2001-03-30
19837	SUPPL	2001-03-30
68840	SUPPL	1900-01-01
67188	ORIG	1900-01-01
67175	ORIG	1900-01-01
54137	SUPPL	1900-01-01
54136	SUPPL	1900-01-01
53439	ORIG	1900-01-01
53438	ORIG	1900-01-01