Application 022108

Type: NDA
Sponsor: VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	APLENZIN	BUPROPION HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	174MG	Yes	No
002	APLENZIN	BUPROPION HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	348MG	Yes	No
003	APLENZIN	BUPROPION HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	522MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84109	SUPPL	2025-11-06
84108	SUPPL	2025-11-06
84086	SUPPL	2025-11-06
78437	SUPPL	2024-05-08
78421	SUPPL	2024-05-07
70496	SUPPL	2022-03-11
70495	SUPPL	2022-03-11
70439	SUPPL	2022-03-09
68068	SUPPL	2021-07-13
68067	SUPPL	2021-07-13
68042	SUPPL	2021-07-12
62819	SUPPL	2020-05-05
62813	SUPPL	2020-05-04
62812	SUPPL	2020-05-04
48300	SUPPL	2017-05-09
48259	SUPPL	2017-05-05
48256	SUPPL	2017-05-05
45216	SUPPL	2016-08-30
45187	SUPPL	2016-08-30
38261	SUPPL	2015-01-09
6906	SUPPL	2015-01-07
16956	SUPPL	2014-07-11
29263	SUPPL	2014-07-10
29262	SUPPL	2012-08-17
16955	SUPPL	2012-08-15
29261	SUPPL	2011-07-28
29260	SUPPL	2011-07-28
38260	SUPPL	2011-07-27
16954	SUPPL	2011-07-27
29259	SUPPL	2011-05-04
6905	SUPPL	2011-05-04
16953	SUPPL	2011-05-02
42417	ORIG	2009-04-07
24242	ORIG	2009-04-07
16952	ORIG	2008-05-27
6904	ORIG	2008-04-24

Application 022108

Related Records#

Application Products#

NDC Listings For This Application#

Documents#