Application 021976

Type: NDA
Sponsor: JANSSEN PRODS

Related Records

Company: JANSSEN PRODS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREZISTA	DARUNAVIR	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	PREZISTA	DARUNAVIR	TABLET;ORAL	600MG	Yes	No
003	PREZISTA	DARUNAVIR	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	PREZISTA	DARUNAVIR	TABLET;ORAL	75MG	Yes	No
005	PREZISTA	DARUNAVIR	TABLET;ORAL	150MG	Yes	No
006	PREZISTA	DARUNAVIR	TABLET;ORAL	800MG	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1327	PREZISTA	darunavir	A-S Medication Solutions	NDA	Current
50090-1491	PREZISTA	darunavir	A-S Medication Solutions	NDA	Current
50090-1491	PREZISTA	darunavir	A-S Medication Solutions	NDA	Current
53808-0672	PREZISTA	darunavir ethanolate	State of Florida DOH Central Pharmacy	NDA	Current
53808-0773	PREZISTA	darunavir ethanolate	State of Florida DOH Central Pharmacy	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-562	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-563	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-564	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-566	PREZISTA	darunavir	Janssen Products LP	NDA	Current
70518-0689	PREZISTA	darunavir	REMEDYREPACK INC.	NDA	Current
70518-1483	PREZISTA	darunavir	REMEDYREPACK INC.	NDA	Current
70518-1483	PREZISTA	darunavir	REMEDYREPACK INC.	NDA	Current
70518-1483	PREZISTA	darunavir	REMEDYREPACK INC.	NDA	Current
70518-1483	PREZISTA	darunavir	REMEDYREPACK INC.	NDA	Current
70518-1483	PREZISTA	darunavir	REMEDYREPACK INC.	NDA	Current
70518-1483	PREZISTA	darunavir	REMEDYREPACK INC.	NDA	Current

Documents

Document	Submission type	Date
73925	SUPPL	2023-04-03
72458	SUPPL	2022-10-24
72441	SUPPL	2022-10-21
70775	SUPPL	2022-04-15
70772	SUPPL	2022-04-15
68739	SUPPL	2021-09-23
68399	SUPPL	2021-08-18
68205	SUPPL	2021-07-27
68188	SUPPL	2021-07-26
65757	SUPPL	2020-12-28
65719	SUPPL	2020-12-23
58959	SUPPL	2019-06-04
58881	SUPPL	2019-05-30
58068	SUPPL	2019-03-25
58062	SUPPL	2019-03-22
57560	SUPPL	2019-02-13
57406	SUPPL	2019-02-01
55441	SUPPL	2018-09-12
55420	SUPPL	2018-09-10
52423	SUPPL	2018-02-06
52100	SUPPL	2018-01-30
48895	SUPPL	2017-07-05
48793	SUPPL	2017-06-22
45335	SUPPL	2016-09-20
45309	SUPPL	2016-09-15
37974	SUPPL	2016-06-21
28953	SUPPL	2016-06-21
37973	SUPPL	2015-05-29
6566	SUPPL	2015-05-28
16669	SUPPL	2015-04-02
28952	SUPPL	2015-04-01
28951	SUPPL	2014-04-08
16668	SUPPL	2014-04-08
16667	SUPPL	2013-11-08
6565	SUPPL	2013-11-08
16664	SUPPL	2013-04-29
6563	SUPPL	2013-04-25
28950	SUPPL	2013-02-26
16666	SUPPL	2013-02-26
37972	SUPPL	2013-02-06
16665	SUPPL	2013-02-06
28949	SUPPL	2013-02-04
6564	SUPPL	2013-02-04
37971	SUPPL	2012-11-15
28948	SUPPL	2012-06-07
16663	SUPPL	2012-06-06
16662	SUPPL	2012-02-24
6562	SUPPL	2012-02-23
6561	SUPPL	2012-02-15
37970	SUPPL	2012-02-14
28947	SUPPL	2011-12-27
16661	SUPPL	2011-12-23
37969	SUPPL	2011-10-25
6560	SUPPL	2011-10-24
6559	SUPPL	2010-12-15
16660	SUPPL	2010-12-13
16659	SUPPL	2010-05-03
28946	SUPPL	2010-04-29
28945	SUPPL	2010-02-05
6558	SUPPL	2010-02-05
37968	SUPPL	2010-02-04
16658	SUPPL	2010-02-04
37967	SUPPL	2009-06-22
16657	SUPPL	2009-06-22
6557	SUPPL	2009-06-17
6556	SUPPL	2009-06-17
16656	SUPPL	2009-01-02
28944	SUPPL	2008-12-29
16655	SUPPL	2008-11-07
6555	SUPPL	2008-10-23
6554	SUPPL	2008-10-23
37965	SUPPL	2008-03-12
37964	SUPPL	2008-03-12
28942	SUPPL	2008-03-11
6553	SUPPL	2008-03-11
28943	SUPPL	2008-02-27
37966	SUPPL	2008-02-26
51506	SUPPL	2007-08-16
44163	ORIG	2006-12-08
28941	SUPPL	2006-12-04
16654	SUPPL	2006-11-22
51504	SUPPL	2006-11-17
21890	ORIG	2006-09-06
16653	ORIG	2006-06-28
28940	ORIG	2006-06-27
52599	ORIG	1900-01-01
52598	ORIG	1900-01-01