Application 020281

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULTRAM	TRAMADOL HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
002	ULTRAM	TRAMADOL HYDROCHLORIDE	TABLET;ORAL	50MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals,	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76230	ORIG	2023-11-03
73501	SUPPL	2023-02-14
73500	SUPPL	2023-02-14
73491	SUPPL	2023-02-14
68609	SUPPL	2021-09-14
68608	SUPPL	2021-09-13
68607	SUPPL	2021-09-13
66585	SUPPL	2021-03-08
66584	SUPPL	2021-03-08
66506	SUPPL	2021-03-05
60342	SUPPL	2019-10-08
60327	SUPPL	2019-10-08
60326	SUPPL	2019-10-08
58278	SUPPL	2019-04-10
58263	SUPPL	2019-04-09
57644	ORIG	2019-02-15
55875	SUPPL	2018-10-11
55874	SUPPL	2018-10-11
55679	SUPPL	2018-10-01
55678	SUPPL	2018-10-01
49625	SUPPL	2017-08-30
49595	SUPPL	2017-08-30
46386	SUPPL	2016-12-21
46385	SUPPL	2016-12-21
46252	SUPPL	2016-12-20
46251	SUPPL	2016-12-20
24731	SUPPL	2009-11-12
24730	SUPPL	2009-11-12
34472	SUPPL	2009-10-06
12419	SUPPL	2009-10-06
24728	SUPPL	2004-06-29
24727	SUPPL	2004-06-29
34471	SUPPL	2004-05-03
2293	SUPPL	2004-04-20
20585	SUPPL	2003-08-07
20584	SUPPL	2003-08-07
34470	SUPPL	2003-04-22
34469	SUPPL	1999-12-23
24729	SUPPL	1999-12-23