FDA.reportPublic FDA data

Application 009218

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
005COUMADINWARFARIN SODIUMTABLET;ORAL10MGYesYes
007COUMADINWARFARIN SODIUMTABLET;ORAL5MGYesNo
012COUMADINWARFARIN SODIUMINJECTABLE;INJECTION75MG/VIALNoNo
013COUMADINWARFARIN SODIUMTABLET;ORAL2MGYesNo
016COUMADINWARFARIN SODIUMTABLET;ORAL7.5MGYesNo
018COUMADINWARFARIN SODIUMTABLET;ORAL2.5MGYesNo
020COUMADINWARFARIN SODIUMINJECTABLE;INJECTION50MG/VIALNoNo
022COUMADINWARFARIN SODIUMTABLET;ORAL1MGYesNo
023COUMADINWARFARIN SODIUMTABLET;ORAL4MGYesNo
024COUMADINWARFARIN SODIUMINJECTABLE;INJECTION5MG/VIALNoNo
025COUMADINWARFARIN SODIUMTABLET;ORAL3MGYesNo
026COUMADINWARFARIN SODIUMTABLET;ORAL6MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0056-0168COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0168COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0168COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0169COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0169COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0169COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0170COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0170COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0170COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0172COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0172COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0172COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0173COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0173COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0174COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0174COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0176COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0176COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0176COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0188COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0188COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0188COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0189COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0189COUMADINwarfarin sodiumBristol-Myers Squibb Pharma CompanyNDACurrent
43353-491COUMADINwarfarin sodiumAphena Pharma Solutions - Tennessee, Inc.NDACurrent
43353-492COUMADINwarfarin sodiumAphena Pharma Solutions - Tennessee, Inc.NDACurrent
43353-493COUMADINwarfarin sodiumAphena Pharma Solutions - Tennessee, Inc.NDACurrent
43353-494COUMADINwarfarin sodiumAphena Pharma Solutions - Tennessee, Inc.NDACurrent
50090-0028COUMADINwarfarin sodiumA-S Medication SolutionsNDACurrent
50090-0028COUMADINwarfarin sodiumA-S Medication SolutionsNDACurrent
55154-7701COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7701COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7701COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7702COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7702COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7702COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7703COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7703COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7704COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7704COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7704COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7706COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7706COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7706COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7716COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7716COUMADINwarfarin sodiumCardinal HealthNDACurrent
55154-7716COUMADINwarfarin sodiumCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56240SUPPL2018-11-01
49486SUPPL2017-08-21
49429SUPPL2017-08-16
48516SUPPL2017-05-24
45278SUPPL2016-09-12
45265SUPPL2016-09-09
183SUPPL2015-10-30
10723SUPPL2015-10-29
32995SUPPL2011-10-05
182SUPPL2011-10-05
11872SUPPL2010-01-28
10722SUPPL2010-01-24
181SUPPL2007-08-17
32994SUPPL2007-08-16
11871SUPPL2006-10-05
10721SUPPL2006-10-05
32993SUPPL2005-09-07
180SUPPL2005-09-07
40658SUPPL2005-09-02
11870SUPPL2002-05-03
179SUPPL2002-05-03
20020SUPPL2000-02-17
40657SUPPL1998-06-01
40656SUPPL1998-06-01
20019SUPPL1998-06-01