Application 202895

Type: NDA
Sponsor: JANSSEN PRODS

Related Records

Company: JANSSEN PRODS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREZISTA	DARUNAVIR	SUSPENSION;ORAL	100MG/ML	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current

Documents

Document	Submission type	Date
73940	SUPPL	2023-04-03
73926	SUPPL	2023-04-03
72459	SUPPL	2022-10-24
72442	SUPPL	2022-10-21
70776	SUPPL	2022-04-15
70773	SUPPL	2022-04-15
68402	SUPPL	2021-08-18
68206	SUPPL	2021-07-27
68189	SUPPL	2021-07-26
65756	SUPPL	2020-12-28
65718	SUPPL	2020-12-23
58960	SUPPL	2019-06-04
58882	SUPPL	2019-05-30
58069	SUPPL	2019-03-25
58063	SUPPL	2019-03-22
57561	SUPPL	2019-02-13
57405	SUPPL	2019-02-01
55440	SUPPL	2018-09-12
52424	SUPPL	2018-02-06
52098	SUPPL	2018-01-30
48896	SUPPL	2017-07-05
48792	SUPPL	2017-06-22
45336	SUPPL	2016-09-20
45308	SUPPL	2016-09-15
40240	SUPPL	2016-06-21
10134	SUPPL	2016-06-21
19400	SUPPL	2015-05-29
32338	SUPPL	2015-05-28
40239	SUPPL	2015-04-02
10133	SUPPL	2015-04-01
40238	SUPPL	2014-04-08
32337	SUPPL	2014-04-08
19399	SUPPL	2013-11-08
10132	SUPPL	2013-11-08
19396	SUPPL	2013-04-29
32334	SUPPL	2013-04-25
40237	SUPPL	2013-02-26
32336	SUPPL	2013-02-26
19398	SUPPL	2013-02-06
19397	SUPPL	2013-02-06
32335	SUPPL	2013-02-04
10131	SUPPL	2013-02-04
40236	SUPPL	2012-11-15
10130	SUPPL	2012-11-14
24423	ORIG	2012-09-06
22903	ORIG	2012-09-06
10129	SUPPL	2012-06-07
40235	SUPPL	2012-06-05
40234	SUPPL	2012-03-15
32333	SUPPL	2012-02-29
10128	ORIG	2011-12-27
40233	ORIG	2011-12-23
51507	ORIG	2007-08-16
51505	ORIG	2006-11-17
63517	ORIG	1900-01-01
63516	ORIG	1900-01-01
63515	ORIG	1900-01-01
52600	ORIG	1900-01-01