Application 021299

Type: NDA
Sponsor: SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEXEVA	PAROXETINE MESYLATE	TABLET;ORAL	EQ 10MG BASE	Yes	No
002	PEXEVA	PAROXETINE MESYLATE	TABLET;ORAL	EQ 20MG BASE	Yes	No
003	PEXEVA	PAROXETINE MESYLATE	TABLET;ORAL	EQ 30MG BASE	Yes	No
004	PEXEVA	PAROXETINE MESYLATE	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
54766-201	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-201	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-201	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-201	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-201	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-201	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-202	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-202	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-202	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-202	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-202	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-202	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-203	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-203	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-203	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-203	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-203	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-203	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-204	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-204	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-204	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-204	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-204	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current
54766-204	PEXEVA	paroxetine mesylate	Sebela Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75241	SUPPL	2023-08-22
75240	SUPPL	2023-08-22
75193	SUPPL	2023-08-22
75192	SUPPL	2023-08-22
75191	SUPPL	2023-08-22
68703	SUPPL	2021-09-21
68702	SUPPL	2021-09-21
68680	SUPPL	2021-09-21
65805	SUPPL	2021-01-04
65804	SUPPL	2021-01-04
46750	SUPPL	2017-01-10
46749	SUPPL	2017-01-10
46697	SUPPL	2017-01-06
4958	SUPPL	2014-07-24
15132	SUPPL	2014-07-23
27411	SUPPL	2012-12-21
27410	SUPPL	2012-12-21
4957	SUPPL	2012-12-21
36607	SUPPL	2011-04-29
4956	SUPPL	2011-04-29
27409	SUPPL	2010-02-05
15130	SUPPL	2010-02-04
15131	SUPPL	2009-02-04
4955	SUPPL	2009-02-03
15129	SUPPL	2008-03-07
4954	SUPPL	2008-03-07
36606	SUPPL	2007-10-10
27408	SUPPL	2007-10-10
42088	SUPPL	2007-09-26
27407	SUPPL	2007-08-07
36605	SUPPL	2007-08-06
23642	ORIG	2007-05-09
27406	SUPPL	2006-12-28
4953	SUPPL	2006-12-28
4952	SUPPL	2006-12-28
36604	SUPPL	2006-12-14
36603	SUPPL	2006-12-14
15128	SUPPL	2006-12-14
36602	SUPPL	2005-01-13
27405	SUPPL	2005-01-13
27404	SUPPL	2004-08-31
42087	ORIG	2004-06-18
36601	ORIG	2004-06-18
15127	ORIG	2004-06-18
4950	ORIG	2004-06-18
4949	ORIG	2004-06-18
4951	SUPPL	2003-08-28

Application 021299

Related Records#

Application Products#

NDC Listings For This Application#

Documents#