Application 020936

Type: NDA
Sponsor: APOTEX TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAXIL CR	PAROXETINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 12.5MG BASE	Yes	No
002	PAXIL CR	PAROXETINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG BASE	Yes	No
003	PAXIL CR	PAROXETINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 37.5MG BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-159	PAXIL	paroxetine hydrochloride	Rebel Distributors Corp	NDA	Current
21695-160	PAXIL	paroxetine hydrochloride	Rebel Distributors Corp	NDA	Current
60505-1316	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1316	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1316	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1316	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1316	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1317	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1317	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1317	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1317	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1317	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1318	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1318	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1318	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1318	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1318	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3673	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3673	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3673	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3673	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3673	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
63629-4615	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Bryant Ranch Prepack	NDA	Current
70518-1791	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1791	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
71335-0572	PAXIL	paroxetine hydrochloride	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77632	SUPPL	2024-02-27
77623	SUPPL	2024-02-26
75228	SUPPL	2023-08-22
75227	SUPPL	2023-08-22
75213	SUPPL	2023-08-22
75212	SUPPL	2023-08-22
75211	SUPPL	2023-08-22
68838	SUPPL	2021-10-01
68837	SUPPL	2021-10-01
68728	SUPPL	2021-09-23
59985	SUPPL	2019-09-12
59984	SUPPL	2019-09-12
59979	SUPPL	2019-09-12
46815	SUPPL	2017-01-13
46696	SUPPL	2017-01-06
35672	SUPPL	2014-07-30
3804	SUPPL	2014-07-23
35671	SUPPL	2012-12-31
26239	SUPPL	2012-12-21
13776	SUPPL	2012-04-17
3803	SUPPL	2012-04-12
41823	SUPPL	2011-12-09
41822	SUPPL	2011-12-09
21287	SUPPL	2011-12-09
21286	SUPPL	2011-12-09
21285	SUPPL	2011-12-09
21284	SUPPL	2011-12-09
13775	SUPPL	2011-07-12
13771	SUPPL	2011-07-12
3802	SUPPL	2011-07-12
3796	SUPPL	2011-07-12
13774	SUPPL	2011-03-28
13773	SUPPL	2011-03-28
3801	SUPPL	2011-03-24
3800	SUPPL	2011-03-24
26238	SUPPL	2010-11-02
35670	SUPPL	2010-10-28
26237	SUPPL	2009-11-19
3797	SUPPL	2009-11-19
35668	SUPPL	2009-11-05
35669	SUPPL	2009-02-04
3799	SUPPL	2009-02-03
13772	SUPPL	2008-11-07
3798	SUPPL	2008-11-03
3794	SUPPL	2007-08-07
41824	SUPPL	2007-08-06
35667	SUPPL	2007-08-03
21289	SUPPL	2007-07-06
26236	SUPPL	2006-09-20
3795	SUPPL	2006-09-20
3792	SUPPL	2006-09-20
26233	SUPPL	2006-03-23
26235	SUPPL	2006-02-08
26234	SUPPL	2006-02-08
3793	SUPPL	2006-02-08
23611	ORIG	2005-08-01
3789	SUPPL	2005-07-15
13770	SUPPL	2005-01-13
3791	SUPPL	2005-01-13
3790	SUPPL	2004-05-27
35666	SUPPL	2004-02-03
26232	SUPPL	2004-02-02
13769	SUPPL	2003-10-17
3788	SUPPL	2003-10-17
26231	SUPPL	2003-09-09
13768	SUPPL	2003-09-09
35665	SUPPL	2002-02-12
26230	SUPPL	2002-02-12
21288	SUPPL	2002-02-12
41821	ORIG	1999-02-16
26229	ORIG	1999-02-16
13767	ORIG	1999-02-16

Application 020936

Related Records#

Application Products#

NDC Listings For This Application#

Documents#