FDA.reportPublic FDA data

Application 022012

Type
NDA
Sponsor
SMITHKLINE BEECHAM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COREG CRCARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORAL10MGYesNo
002COREG CRCARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORAL20MGYesNo
003COREG CRCARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORAL40MGYesYes
004COREG CRCARVEDILOL PHOSPHATECAPSULE, EXTENDED RELEASE;ORAL80MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0007-3370COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3370COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3370COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3370COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3370COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3370COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3371COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3371COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3371COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3371COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3371COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3371COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3372COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3372COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3372COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3372COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3372COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3372COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3373COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3373COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3373COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3373COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3373COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3373COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3383COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3383COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3383COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3383COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3383COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3385COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3385COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3385COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3385COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3385COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3387COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3387COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3387COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3387COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3387COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3388COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3388COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3388COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3388COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
0007-3388COREGcarvedilol phosphateGlaxoSmithKline LLCNDACurrent
60505-3678Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3678Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3678Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3678Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3678Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3679Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3679Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3679Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3679Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3679Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3680Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3680Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3680Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3680Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3680Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3681Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3681Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3681Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3681Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-3681Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4713Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4713Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4713Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4713Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4714Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4714Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4714Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4714Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4715Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4715Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4715Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4715Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4716Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4716Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4716Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent
60505-4716Carvedilol Phosphatecarvedilol phosphateApotex Corp.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74912SUPPL 2023-07-27
74904SUPPL 2023-07-27
49788SUPPL2017-09-19
49745SUPPL2017-09-15
29075SUPPL2015-11-04
16768SUPPL2015-10-08
38084SUPPL2011-07-07
6686SUPPL2011-07-07
29074SUPPL2011-02-02
38081SUPPL2011-01-31
6685SUPPL2011-01-18
38083SUPPL2011-01-10
38082SUPPL2011-01-10
6684SUPPL2011-01-07
38080SUPPL2009-06-29
16767SUPPL2009-06-29
29072SUPPL2009-06-26
6683SUPPL2009-06-26
16766SUPPL2009-01-06
29073SUPPL2008-12-31
38079SUPPL2007-10-22
6682SUPPL2007-10-22
29071SUPPL2007-08-07
16765SUPPL2007-08-06
21906ORIG2007-07-27
29070SUPPL2007-07-24
16764SUPPL2007-07-24
29069ORIG2006-10-23
16763ORIG2006-10-23