FDA.reportPublic FDA data

Application 021515

Type
NDA
Sponsor
VALEANT INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WELLBUTRIN XLBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGYesNo
002WELLBUTRIN XLBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0730WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0730WELLBUTRINbupropion hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-0730WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0730WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0730WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0730WELLBUTRINbupropion hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-0730WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0730WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0730WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0730WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0731WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0731WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0731WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0731WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0731WELLBUTRINbupropion hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-0731WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0731WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0731WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
0187-0731WELLBUTRINbupropion hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-0731WELLBUTRINbupropion hydrochlorideBausch Health US LLCNDACurrent
21695-137WELLBUTRIN XLbupropion hydrochlorideRebel Distributors CorpNDACurrent
21695-138WELLBUTRIN XLbupropion hydrochlorideRebel Distributors CorpNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84111SUPPL 2025-11-06
84110SUPPL 2025-11-06
84085SUPPL 2025-11-06
78436SUPPL 2024-05-08
78435SUPPL 2024-05-08
78422SUPPL 2024-05-07
70494SUPPL2022-03-11
70493SUPPL2022-03-11
70438SUPPL2022-03-09
68066SUPPL2021-07-13
68065SUPPL2021-07-13
68041SUPPL2021-07-12
61006SUPPL2019-11-20
61005SUPPL2019-11-20
60794SUPPL2019-11-08
48299SUPPL2017-05-09
48258SUPPL2017-05-05
48257SUPPL2017-05-05
45206SUPPL2016-08-30
45188SUPPL2016-08-30
5600SUPPL2015-01-07
5599SUPPL2015-01-07
37124SUPPL2015-01-05
15656SUPPL2015-01-05
28004SUPPL2014-07-15
15657SUPPL2014-07-15
28003SUPPL2012-08-03
28002SUPPL2011-07-28
5598SUPPL2011-07-28
37123SUPPL2011-07-27
15655SUPPL2011-07-27
15653SUPPL2010-05-28
27999SUPPL2010-05-27
37122SUPPL2009-07-09
15654SUPPL2009-07-09
28001SUPPL2009-07-08
28000SUPPL2009-07-08
27998SUPPL2007-08-07
15652SUPPL2007-08-03
21709SUPPL2007-06-29
5597SUPPL2006-07-13
37120SUPPL2006-07-05
37121SUPPL2006-06-14
27997SUPPL2006-06-14
27995SUPPL2006-06-14
15651SUPPL2006-06-14
27996SUPPL2006-03-03
23668ORIG2005-07-28
42198ORIG2005-04-27
27994SUPPL2005-01-13
15650SUPPL2005-01-13
5596SUPPL2004-10-29
27993SUPPL2004-06-01
37119ORIG2003-09-09
5595ORIG2003-09-09