Application 202022

Type: NDA
Sponsor: JANSSEN PRODS

Related Records

Company: JANSSEN PRODS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EDURANT	RILPIVIRINE HYDROCHLORIDE	TABLET;ORAL	EQ 25MG BASE	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59676-278	EDURANT	rilpivirine hydrochloride	Janssen Products, LP	NDA	Current
59676-278	EDURANT	rilpivirine hydrochloride	Janssen Products, LP	NDA	Current
59676-278	EDURANT	rilpivirine hydrochloride	Janssen Products, LP	NDA	Current
59676-278	EDURANT	rilpivirine hydrochloride	Janssen Products, LP	NDA	Current
59676-278	EDURANT	rilpivirine hydrochloride	Janssen Products, LP	NDA	Current
59676-278	EDURANT	rilpivirine hydrochloride	Janssen Products, LP	NDA	Current

Documents

Document	Submission type	Date
77853	SUPPL	2024-04-09
77852	SUPPL	2024-04-09
77858	SUPPL	2024-03-18
77857	SUPPL	2024-03-18
72446	SUPPL	2022-10-21
72428	SUPPL	2022-10-20
70663	SUPPL	2022-03-30
70662	SUPPL	2022-03-30
70649	SUPPL	2022-03-30
70648	SUPPL	2022-03-30
70058	SUPPL	2022-02-03
70041	SUPPL	2022-02-01
66013	SUPPL	2021-01-28
65962	SUPPL	2021-01-22
58778	SUPPL	2019-05-17
58725	SUPPL	2019-05-15
52292	SUPPL	2018-02-02
52240	SUPPL	2018-02-01
49790	SUPPL	2017-09-19
49769	SUPPL	2017-09-18
9945	SUPPL	2015-08-28
19047	SUPPL	2015-08-27
32156	SUPPL	2015-05-11
40099	SUPPL	2015-05-07
9944	SUPPL	2014-05-06
40098	SUPPL	2014-05-02
40097	SUPPL	2013-06-25
9943	SUPPL	2013-06-21
32154	SUPPL	2012-12-11
19046	SUPPL	2012-12-10
40096	SUPPL	2012-08-15
32155	SUPPL	2012-08-15
44840	ORIG	2011-07-05
22867	ORIG	2011-07-05
32153	ORIG	2011-05-24
40095	ORIG	2011-05-23
51472	SUPPL	1900-01-01
51471	SUPPL	1900-01-01