Application 019655

Type: NDA
Sponsor: VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RETROVIR	ZIDOVUDINE	CAPSULE;ORAL	100MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current
49702-211	RETROVIR	zidovudine	ViiV Healthcare Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80703	SUPPL	2024-12-23
80649	SUPPL	2024-12-19
65919	SUPPL	2021-01-19
63636	SUPPL	2020-06-19
55435	SUPPL	2018-09-12
55424	SUPPL	2018-09-11
50553	SUPPL	2017-12-01
50526	SUPPL	2017-11-29
48021	SUPPL	2017-04-14
48005	SUPPL	2017-04-13
47438	SUPPL	2017-03-03
47365	SUPPL	2017-02-28
33845	SUPPL	2015-01-08
17530	SUPPL	2014-12-31
33844	SUPPL	2012-06-06
17529	SUPPL	2012-06-04
1469	SUPPL	2011-12-01
11609	SUPPL	2011-11-25
1468	SUPPL	2010-05-21
11608	SUPPL	2010-05-18
17528	SUPPL	2010-01-06
33843	SUPPL	2009-11-23
11607	SUPPL	2008-09-25
17527	SUPPL	2008-09-23
17526	SUPPL	2006-11-22
33842	SUPPL	2006-11-16
17525	SUPPL	2006-05-18
11606	SUPPL	2006-05-16
40959	SUPPL	2005-04-19
33841	SUPPL	2003-10-17
17524	SUPPL	2003-10-17
11605	SUPPL	2003-06-16
33840	SUPPL	2003-04-04
17523	SUPPL	2002-12-18
1467	SUPPL	2002-02-21
33839	SUPPL	2001-03-30
1466	SUPPL	2001-03-30