FDA.reportPublic FDA data

Application 020297

Type
NDA
Sponsor
SMITHKLINE BEECHAM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COREGCARVEDILOLTABLET;ORAL25MGYesNo
002COREGCARVEDILOLTABLET;ORAL12.5MGYesYes
003COREGCARVEDILOLTABLET;ORAL6.25MGYesNo
004COREGCARVEDILOLTABLET;ORAL3.125MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0007-4139COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4139COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4139COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4140COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4140COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4140COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4141COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4141COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4141COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4142COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4142COREGcarvedilolGlaxoSmithKline LLCNDACurrent
0007-4142COREGcarvedilolGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74913SUPPL 2023-10-30
74903SUPPL 2023-10-24
49783SUPPL2017-09-19
49746SUPPL2017-09-15
34493SUPPL2015-10-08
24753SUPPL2015-10-06
34492SUPPL2011-07-12
24752SUPPL2011-07-07
2313SUPPL2011-02-02
12425SUPPL2011-01-31
34491SUPPL2011-01-10
34490SUPPL2011-01-10
24751SUPPL2011-01-07
2314SUPPL2011-01-07
34488SUPPL2009-06-29
2312SUPPL2009-06-26
34489SUPPL2009-01-06
24750SUPPL2008-12-24
34487SUPPL2008-07-23
24749SUPPL2008-07-23
2311SUPPL2007-03-06
12424SUPPL2007-02-26
2310SUPPL2006-12-28
2309SUPPL2006-09-18
2308SUPPL2006-09-18
24134SUPPL2006-09-12
12423SUPPL2006-08-29
2307SUPPL2005-08-19
12422SUPPL2005-05-02
2306SUPPL2005-05-02
24748SUPPL2003-09-30
41274SUPPL2003-07-08
2305SUPPL2003-03-28
41273SUPPL2001-11-01
34486SUPPL2001-11-01
2304SUPPL2001-11-01
41272SUPPL1999-09-08
57427ORIG1993-09-14
53085SUPPL1900-01-01
51806SUPPL1900-01-01
51805SUPPL1900-01-01
51803SUPPL1900-01-01
51802SUPPL1900-01-01
51801SUPPL1900-01-01
51800SUPPL1900-01-01
51799SUPPL1900-01-01
51798SUPPL1900-01-01