Application 020031

Type: NDA
Sponsor: APOTEX TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAXIL	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	Yes	No
002	PAXIL	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 20MG BASE	Yes	No
003	PAXIL	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 30MG BASE	Yes	No
004	PAXIL	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 50MG BASE	No	No
005	PAXIL	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 40MG BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-3663	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3663	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3663	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3664	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3664	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3664	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3665	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3665	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3665	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3666	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3666	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3666	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3666	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4517	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4517	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4517	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4517	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4517	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4518	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4518	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4518	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4518	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4518	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4519	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4519	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4519	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4519	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4519	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4520	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4520	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4520	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4520	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4520	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
70518-2500	PAXIL	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2636	PAXIL	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2636	PAXIL	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2636	PAXIL	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80479	SUPPL	2024-12-03
80457	SUPPL	2024-12-02
80456	SUPPL	2024-12-02
76590	SUPPL	2023-11-16
68842	SUPPL	2021-10-01
68841	SUPPL	2021-10-01
69745	SUPPL	2021-09-30
68726	SUPPL	2021-09-23
66182	SUPPL	2021-02-11
66181	SUPPL	2021-02-11
66134	SUPPL	2021-02-09
46812	SUPPL	2017-01-13
46811	SUPPL	2017-01-13
46694	SUPPL	2017-01-06
12148	SUPPL	2014-07-29
1926	SUPPL	2014-07-23
41125	SUPPL	2014-01-16
34190	SUPPL	2012-12-31
1925	SUPPL	2012-12-21
34191	SUPPL	2012-04-17
21056	SUPPL	2012-04-12
34189	SUPPL	2011-07-12
34186	SUPPL	2011-07-12
1924	SUPPL	2011-07-12
1919	SUPPL	2011-07-12
34192	SUPPL	2011-03-28
12147	SUPPL	2011-03-28
12146	SUPPL	2011-03-28
21057	SUPPL	2011-03-24
1923	SUPPL	2011-03-24
1921	SUPPL	2011-03-24
1922	SUPPL	2010-11-02
34188	SUPPL	2010-10-28
1920	SUPPL	2009-11-19
12144	SUPPL	2009-11-05
34187	SUPPL	2009-02-04
21055	SUPPL	2009-02-03
12145	SUPPL	2008-11-07
21054	SUPPL	2008-11-03
1918	SUPPL	2007-08-07
12143	SUPPL	2007-08-03
41124	SUPPL	2007-07-09
41123	SUPPL	2007-07-09
41122	SUPPL	2007-07-09
20454	SUPPL	2007-07-09
20453	SUPPL	2007-07-09
19951	SUPPL	2006-09-25
19950	SUPPL	2006-09-25
19947	SUPPL	2006-09-25
19946	SUPPL	2006-03-23
19949	SUPPL	2006-02-08
19948	SUPPL	2006-02-08
1917	SUPPL	2006-02-08
44042	ORIG	2005-08-16
1915	SUPPL	2005-07-15
19945	SUPPL	2005-01-13
12142	SUPPL	2005-01-13
20455	SUPPL	2004-09-15
20452	SUPPL	2004-06-29
1916	SUPPL	2004-05-27
19944	SUPPL	2004-04-20
19943	SUPPL	2004-04-20
34184	SUPPL	2003-04-24
19942	SUPPL	2002-10-02
34185	SUPPL	2001-12-14
19941	SUPPL	2001-12-14
19940	SUPPL	2001-04-13
12141	SUPPL	2001-04-13
1914	SUPPL	1999-05-11
53124	ORIG	1900-01-01
53123	ORIG	1900-01-01
53122	ORIG	1900-01-01
53121	ORIG	1900-01-01

Application 020031

Related Records#

Application Products#

NDC Listings For This Application#

Documents#