Warfarin Injectable Solution

Brand(s)
Coumadin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company (2011-10-04)
Oldest Current Product
2009-01-01
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\WARFARIN
FDAOB
INJECTION\INJECTION\WARFARIN SODIUM\rdfq
ORAL\TABLET\WARFARIN POTASSIUM
ORAL\TABLET\WARFARIN SODIUM
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\WARFARIN SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\WARFARIN

product(s) by strength(s)

warfarin sodium 2 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005900324CoumadinNDABristol-Myers Squibb Holdings Pharma, Ltd. Liability Company2009-01-01WARFARIN SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA009218c0f238ff-2804-4150-9766-22a5111b4e74

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040145WARFARIN SODIUMBARR LABORATORIES INC1997-03-26ANDA040145_001, ANDA040145_002, ANDA040145_003, ANDA040145_004, ANDA040145_005, ANDA040145_006, ANDA040145_007, ANDA040145_008, ANDA040145_009Warfarin Oral Tablet
2ANDA040196WARFARIN SODIUMTrueSANDOZ INC1997-09-30ANDA040196_001, ANDA040196_002, ANDA040196_003, ANDA040196_004, ANDA040196_005, ANDA040196_006, ANDA040196_007, ANDA040196_008, ANDA040196_009Warfarin Oral Tablet
3ANDA040301WARFARIN SODIUMTARO PHARMACEUTICALS INC1999-07-15ANDA040301_001, ANDA040301_002, ANDA040301_003, ANDA040301_004, ANDA040301_005, ANDA040301_006, ANDA040301_007, ANDA040301_008, ANDA040301_009Warfarin Oral Tablet
4ANDA040415WARFARIN SODIUMMYLAN PHARMACEUTICALS INC2004-09-27ANDA040415_001, ANDA040415_002, ANDA040415_003, ANDA040415_004, ANDA040415_005, ANDA040415_006, ANDA040415_007, ANDA040415_008, ANDA040415_009Warfarin Oral Tablet
5ANDA040416JANTOVENUSL PHARMA INC2003-10-02ANDA040416_001, ANDA040416_002, ANDA040416_003, ANDA040416_004, ANDA040416_005, ANDA040416_006, ANDA040416_007, ANDA040416_008, ANDA040416_009Warfarin Oral Tablet
6ANDA040616WARFARIN SODIUMPLIVA INC2006-07-05ANDA040616_001, ANDA040616_002, ANDA040616_003, ANDA040616_004, ANDA040616_005, ANDA040616_006, ANDA040616_007, ANDA040616_008, ANDA040616_009Warfarin Oral Tablet
7ANDA040663WARFARIN SODIUMZYDUS PHARMACEUTICALS USA INC2006-05-30ANDA040663_001, ANDA040663_002, ANDA040663_003, ANDA040663_004, ANDA040663_005, ANDA040663_006, ANDA040663_007, ANDA040663_008, ANDA040663_009Warfarin Oral Tablet
8ANDA086118WARFARIN SODIUMTrueWATSON LABORATORIES INC1982-08-17ANDA086118_001Warfarin Oral Tablet
9ANDA086119WARFARIN SODIUMTrueWATSON LABORATORIES INC1982-08-17ANDA086119_001Warfarin Oral Tablet
10ANDA086120WARFARIN SODIUMTrueWATSON LABORATORIES INC1982-08-17ANDA086120_001Warfarin Oral Tablet
11ANDA086122WARFARIN SODIUMTrueWATSON LABORATORIES INC1982-08-17ANDA086122_001Warfarin Oral Tablet
12ANDA086123WARFARIN SODIUMTrueWATSON LABORATORIES INC1982-08-17ANDA086123_001Warfarin Oral Tablet
13ANDA088719WARFARIN SODIUMTrueUSL PHARMA INC1985-06-27ANDA088719_001Warfarin Oral Tablet
14ANDA088720WARFARIN SODIUMTrueUSL PHARMA INC1985-08-06ANDA088720_001Warfarin Oral Tablet
15ANDA088721WARFARIN SODIUMTrueUSL PHARMA INC1985-07-02ANDA088721_001Warfarin Oral Tablet
16ANDA090935WARFARIN SODIUMINVAGEN PHARMACEUTICALS INC2011-05-25ANDA090935_001, ANDA090935_002, ANDA090935_003, ANDA090935_004, ANDA090935_005, ANDA090935_006, ANDA090935_007, ANDA090935_008, ANDA090935_009Warfarin Oral Tablet
17ANDA200104WARFARIN SODIUMIPCA LABORATORIES LTD2013-06-27ANDA200104_001, ANDA200104_002, ANDA200104_003, ANDA200104_004, ANDA200104_005, ANDA200104_006, ANDA200104_007, ANDA200104_008, ANDA200104_009Warfarin Oral Tablet
18ANDA202202WARFARIN SODIUMAMNEAL PHARMACEUTICALS2013-03-04ANDA202202_001, ANDA202202_002, ANDA202202_003, ANDA202202_004, ANDA202202_005, ANDA202202_006, ANDA202202_007, ANDA202202_008, ANDA202202_009Warfarin Oral Tablet
19NDA009218COUMADINBRISTOL MYERS SQUIBB PHARMA CONDA009218_005, NDA009218_007, NDA009218_012, NDA009218_013, NDA009218_016, NDA009218_018, NDA009218_020, NDA009218_022, NDA009218_023, NDA009218_024, NDA009218_025, NDA009218_026Warfarin Oral Tablet
20NDA011771ATHROMBINTruePHARMACEUTICAL RESEARCH ASSOC INCNDA011771_001, NDA011771_002, NDA011771_003, NDA011771_004, NDA011771_005, NDA011771_006, NDA011771_007Warfarin Oral Tablet
21NDA017020PANWARFINTrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVNDA017020_001, NDA017020_002, NDA017020_003, NDA017020_004, NDA017020_005Warfarin Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040145_001RXWARFARIN SODIUM (1MG)ORALTABLETFalseAB1997-03-26WARFARIN SODIUM
2ANDA040145_002RXWARFARIN SODIUM (2MG)ORALTABLETFalseAB1997-03-26WARFARIN SODIUM
3ANDA040145_003RXWARFARIN SODIUM (2.5MG)ORALTABLETFalseAB1997-03-26WARFARIN SODIUM
4ANDA040145_004RXWARFARIN SODIUM (4MG)ORALTABLETFalseAB1997-03-26WARFARIN SODIUM
5ANDA040145_005RXWARFARIN SODIUM (5MG)ORALTABLETFalseAB1997-03-26WARFARIN SODIUM
6ANDA040145_006RXWARFARIN SODIUM (7.5MG)ORALTABLETFalseAB1997-03-26WARFARIN SODIUM
7ANDA040145_007RXWARFARIN SODIUM (10MG)ORALTABLETFalseAB1997-03-26WARFARIN SODIUM
8ANDA040145_008RXWARFARIN SODIUM (3MG)ORALTABLETFalseAB1998-11-05WARFARIN SODIUM
9ANDA040145_009RXWARFARIN SODIUM (6MG)ORALTABLETFalseAB1998-11-05WARFARIN SODIUM
10ANDA040196_001discontinuedWARFARIN SODIUM (1MG)ORALTABLETFalse1997-09-30WARFARIN SODIUM
11ANDA040196_002discontinuedWARFARIN SODIUM (2MG)ORALTABLETFalse1997-09-30WARFARIN SODIUM
12ANDA040196_003discontinuedWARFARIN SODIUM (2.5MG)ORALTABLETFalse1997-09-30WARFARIN SODIUM
13ANDA040196_004discontinuedWARFARIN SODIUM (4MG)ORALTABLETFalse1997-09-30WARFARIN SODIUM
14ANDA040196_005discontinuedWARFARIN SODIUM (5MG)ORALTABLETFalse1997-09-30WARFARIN SODIUM
15ANDA040196_006discontinuedWARFARIN SODIUM (7.5MG)ORALTABLETFalse1997-09-30WARFARIN SODIUM
16ANDA040196_007discontinuedWARFARIN SODIUM (10MG)ORALTABLETFalse1997-09-30WARFARIN SODIUM
17ANDA040196_008discontinuedWARFARIN SODIUM (3MG)ORALTABLETFalse2000-07-26WARFARIN SODIUM
18ANDA040196_009discontinuedWARFARIN SODIUM (6MG)ORALTABLETFalse2000-07-26WARFARIN SODIUM
19ANDA040301_001RXWARFARIN SODIUM (10MG)ORALTABLETFalseAB1999-07-15WARFARIN SODIUM
20ANDA040301_002RXWARFARIN SODIUM (1MG)ORALTABLETFalseAB1999-07-15WARFARIN SODIUM
21ANDA040301_003RXWARFARIN SODIUM (2MG)ORALTABLETFalseAB1999-07-15WARFARIN SODIUM
22ANDA040301_004RXWARFARIN SODIUM (2.5MG)ORALTABLETFalseAB1999-07-15WARFARIN SODIUM
23ANDA040301_005RXWARFARIN SODIUM (3MG)ORALTABLETFalseAB1999-07-15WARFARIN SODIUM
24ANDA040301_006RXWARFARIN SODIUM (4MG)ORALTABLETFalseAB1999-07-15WARFARIN SODIUM
25ANDA040301_007RXWARFARIN SODIUM (5MG)ORALTABLETFalseAB1999-07-15WARFARIN SODIUM
26ANDA040301_008RXWARFARIN SODIUM (6MG)ORALTABLETFalseAB1999-07-15WARFARIN SODIUM
27ANDA040301_009RXWARFARIN SODIUM (7.5MG)ORALTABLETFalseAB1999-07-15WARFARIN SODIUM
28ANDA040415_001RXWARFARIN SODIUM (1MG)ORALTABLETFalseAB2004-09-27WARFARIN SODIUM
29ANDA040415_002RXWARFARIN SODIUM (2MG)ORALTABLETFalseAB2004-09-27WARFARIN SODIUM
30ANDA040415_003RXWARFARIN SODIUM (2.5MG)ORALTABLETFalseAB2004-09-29WARFARIN SODIUM
31ANDA040415_004RXWARFARIN SODIUM (3MG)ORALTABLETFalseAB2004-09-27WARFARIN SODIUM
32ANDA040415_005RXWARFARIN SODIUM (4MG)ORALTABLETFalseAB2004-09-27WARFARIN SODIUM
33ANDA040415_006RXWARFARIN SODIUM (5MG)ORALTABLETFalseAB2004-09-27WARFARIN SODIUM
34ANDA040415_007RXWARFARIN SODIUM (6MG)ORALTABLETFalseAB2004-09-27WARFARIN SODIUM
35ANDA040415_008RXWARFARIN SODIUM (7.5MG)ORALTABLETFalseAB2004-09-27WARFARIN SODIUM
36ANDA040415_009RXWARFARIN SODIUM (10MG)ORALTABLETFalseAB2004-09-27WARFARIN SODIUM
37ANDA040416_001RXWARFARIN SODIUM (1MG)ORALTABLETFalseAB2003-10-02JANTOVEN
38ANDA040416_002RXWARFARIN SODIUM (2MG)ORALTABLETFalseAB2003-10-02JANTOVEN
39ANDA040416_003RXWARFARIN SODIUM (2.5MG)ORALTABLETFalseAB2003-10-02JANTOVEN
40ANDA040416_004RXWARFARIN SODIUM (3MG)ORALTABLETFalseAB2003-10-02JANTOVEN
41ANDA040416_005RXWARFARIN SODIUM (4MG)ORALTABLETFalseAB2003-10-02JANTOVEN
42ANDA040416_006RXWARFARIN SODIUM (5MG)ORALTABLETFalseAB2003-10-02JANTOVEN
43ANDA040416_007RXWARFARIN SODIUM (6MG)ORALTABLETFalseAB2003-10-02JANTOVEN
44ANDA040416_008RXWARFARIN SODIUM (7.5MG)ORALTABLETFalseAB2003-10-02JANTOVEN
45ANDA040416_009RXWARFARIN SODIUM (10MG)ORALTABLETFalseAB2003-10-02JANTOVEN
46ANDA040616_001RXWARFARIN SODIUM (2MG)ORALTABLETFalseAB2006-07-05WARFARIN SODIUM
47ANDA040616_002RXWARFARIN SODIUM (2.5MG)ORALTABLETFalseAB2006-07-05WARFARIN SODIUM
48ANDA040616_003RXWARFARIN SODIUM (3MG)ORALTABLETFalseAB2006-07-05WARFARIN SODIUM
49ANDA040616_004RXWARFARIN SODIUM (4MG)ORALTABLETFalseAB2006-07-05WARFARIN SODIUM
50ANDA040616_005RXWARFARIN SODIUM (5MG)ORALTABLETFalseAB2006-07-05WARFARIN SODIUM
51ANDA040616_006RXWARFARIN SODIUM (6MG)ORALTABLETFalseAB2006-07-05WARFARIN SODIUM
52ANDA040616_007RXWARFARIN SODIUM (7.5MG)ORALTABLETFalseAB2006-07-05WARFARIN SODIUM
53ANDA040616_008RXWARFARIN SODIUM (10MG)ORALTABLETFalseAB2006-07-05WARFARIN SODIUM
54ANDA040616_009RXWARFARIN SODIUM (1MG)ORALTABLETFalseAB2006-07-05WARFARIN SODIUM
55ANDA040663_001RXWARFARIN SODIUM (1MG)ORALTABLETFalseAB2006-05-30WARFARIN SODIUM
56ANDA040663_002RXWARFARIN SODIUM (2MG)ORALTABLETFalseAB2006-05-30WARFARIN SODIUM
57ANDA040663_003RXWARFARIN SODIUM (2.5MG)ORALTABLETFalseAB2006-05-30WARFARIN SODIUM
58ANDA040663_004RXWARFARIN SODIUM (3MG)ORALTABLETFalseAB2006-05-30WARFARIN SODIUM
59ANDA040663_005RXWARFARIN SODIUM (4MG)ORALTABLETFalseAB2006-05-30WARFARIN SODIUM
60ANDA040663_006RXWARFARIN SODIUM (5MG)ORALTABLETFalseAB2006-05-30WARFARIN SODIUM
61ANDA040663_007RXWARFARIN SODIUM (6MG)ORALTABLETFalseAB2006-05-30WARFARIN SODIUM
62ANDA040663_008RXWARFARIN SODIUM (7.5MG)ORALTABLETFalseAB2006-05-30WARFARIN SODIUM
63ANDA040663_009RXWARFARIN SODIUM (10MG)ORALTABLETFalseAB2006-05-30WARFARIN SODIUM
64ANDA086118_001discontinuedWARFARIN SODIUM (7.5MG)ORALTABLETFalse1982-08-17WARFARIN SODIUM
65ANDA086119_001discontinuedWARFARIN SODIUM (5MG)ORALTABLETFalse1982-08-17WARFARIN SODIUM
66ANDA086120_001discontinuedWARFARIN SODIUM (2.5MG)ORALTABLETFalse1982-08-17WARFARIN SODIUM
67ANDA086122_001discontinuedWARFARIN SODIUM (10MG)ORALTABLETFalse1982-08-17WARFARIN SODIUM
68ANDA086123_001discontinuedWARFARIN SODIUM (2MG)ORALTABLETFalse1982-08-17WARFARIN SODIUM
69ANDA088719_001discontinuedWARFARIN SODIUM (2MG)ORALTABLETFalse1985-06-27WARFARIN SODIUM
70ANDA088720_001discontinuedWARFARIN SODIUM (2.5MG)ORALTABLETFalse1985-08-06WARFARIN SODIUM
71ANDA088721_001discontinuedWARFARIN SODIUM (5MG)ORALTABLETFalse1985-07-02WARFARIN SODIUM
72ANDA090935_001RXWARFARIN SODIUM (1MG)ORALTABLETFalseAB2011-05-25WARFARIN SODIUM
73ANDA090935_002RXWARFARIN SODIUM (2MG)ORALTABLETFalseAB2011-05-25WARFARIN SODIUM
74ANDA090935_003RXWARFARIN SODIUM (2.5MG)ORALTABLETFalseAB2011-05-25WARFARIN SODIUM
75ANDA090935_004RXWARFARIN SODIUM (3MG)ORALTABLETFalseAB2011-05-25WARFARIN SODIUM
76ANDA090935_005RXWARFARIN SODIUM (4MG)ORALTABLETFalseAB2011-05-25WARFARIN SODIUM
77ANDA090935_006RXWARFARIN SODIUM (5MG)ORALTABLETFalseAB2011-05-25WARFARIN SODIUM
78ANDA090935_007RXWARFARIN SODIUM (6MG)ORALTABLETFalseAB2011-05-25WARFARIN SODIUM
79ANDA090935_008RXWARFARIN SODIUM (7.5MG)ORALTABLETFalseAB2011-05-25WARFARIN SODIUM
80ANDA090935_009RXWARFARIN SODIUM (10MG)ORALTABLETFalseAB2011-05-25WARFARIN SODIUM
81ANDA200104_001RXWARFARIN SODIUM (1MG)ORALTABLETFalseAB2013-06-27WARFARIN SODIUM
82ANDA200104_002RXWARFARIN SODIUM (2MG)ORALTABLETFalseAB2013-06-27WARFARIN SODIUM
83ANDA200104_003RXWARFARIN SODIUM (2.5MG)ORALTABLETFalseAB2013-06-27WARFARIN SODIUM
84ANDA200104_004RXWARFARIN SODIUM (3MG)ORALTABLETFalseAB2013-06-27WARFARIN SODIUM
85ANDA200104_005RXWARFARIN SODIUM (4MG)ORALTABLETFalseAB2013-06-27WARFARIN SODIUM
86ANDA200104_006RXWARFARIN SODIUM (5MG)ORALTABLETFalseAB2013-06-27WARFARIN SODIUM
87ANDA200104_007RXWARFARIN SODIUM (6MG)ORALTABLETFalseAB2013-06-27WARFARIN SODIUM
88ANDA200104_008RXWARFARIN SODIUM (7.5MG)ORALTABLETFalseAB2013-06-27WARFARIN SODIUM
89ANDA200104_009RXWARFARIN SODIUM (10MG)ORALTABLETFalseAB2013-06-27WARFARIN SODIUM
90ANDA202202_001RXWARFARIN SODIUM (1MG)ORALTABLETFalseAB2013-03-04WARFARIN SODIUM
91ANDA202202_002RXWARFARIN SODIUM (2MG)ORALTABLETFalseAB2013-03-04WARFARIN SODIUM
92ANDA202202_003RXWARFARIN SODIUM (2.5MG)ORALTABLETFalseAB2013-03-04WARFARIN SODIUM
93ANDA202202_004RXWARFARIN SODIUM (3MG)ORALTABLETFalseAB2013-03-04WARFARIN SODIUM
94ANDA202202_005RXWARFARIN SODIUM (4MG)ORALTABLETFalseAB2013-03-04WARFARIN SODIUM
95ANDA202202_006RXWARFARIN SODIUM (5MG)ORALTABLETFalseAB2013-03-04WARFARIN SODIUM
96ANDA202202_007RXWARFARIN SODIUM (6MG)ORALTABLETFalseAB2013-03-04WARFARIN SODIUM
97ANDA202202_008RXWARFARIN SODIUM (7.5MG)ORALTABLETFalseAB2013-03-04WARFARIN SODIUM
98ANDA202202_009RXWARFARIN SODIUM (10MG)ORALTABLETFalseAB2013-03-04WARFARIN SODIUM
99NDA009218_005RXWARFARIN SODIUM (10MG)ORALTABLETTrueABCOUMADIN
100NDA009218_007RXWARFARIN SODIUM (5MG)ORALTABLETFalseABCOUMADIN
101NDA009218_012discontinuedWARFARIN SODIUM (75MG/VIAL)INJECTIONFalseCOUMADIN
102NDA009218_013RXWARFARIN SODIUM (2MG)ORALTABLETFalseABCOUMADIN
103NDA009218_016RXWARFARIN SODIUM (7.5MG)ORALTABLETFalseABCOUMADIN
104NDA009218_018RXWARFARIN SODIUM (2.5MG)ORALTABLETFalseABCOUMADIN
105NDA009218_020discontinuedWARFARIN SODIUM (50MG/VIAL)INJECTIONFalseCOUMADIN
106NDA009218_022RXWARFARIN SODIUM (1MG)ORALTABLETFalseAB1990-03-01COUMADIN
107NDA009218_023RXWARFARIN SODIUM (4MG)ORALTABLETFalseAB1993-08-24COUMADIN
108NDA009218_024discontinuedWARFARIN SODIUM (5MG/VIAL)INJECTIONFalse1995-02-07COUMADIN
109NDA009218_025RXWARFARIN SODIUM (3MG)ORALTABLETFalseAB1996-11-18COUMADIN
110NDA009218_026RXWARFARIN SODIUM (6MG)ORALTABLETFalseAB1996-11-18COUMADIN
111NDA011771_001discontinuedWARFARIN SODIUM (25MG)ORALTABLETFalseATHROMBIN
112NDA011771_002discontinuedWARFARIN SODIUM (10MG)ORALTABLETFalseATHROMBIN
113NDA011771_003discontinuedWARFARIN SODIUM (5MG)ORALTABLETFalseATHROMBIN
114NDA011771_004discontinuedWARFARIN POTASSIUM (5MG)ORALTABLETFalseATHROMBIN
115NDA011771_005discontinuedWARFARIN POTASSIUM (10MG)ORALTABLETFalseATHROMBIN
116NDA011771_006discontinuedWARFARIN POTASSIUM (25MG)ORALTABLETFalseATHROMBIN
117NDA011771_007discontinuedWARFARIN POTASSIUM (2MG)ORALTABLETFalseATHROMBIN
118NDA017020_001discontinuedWARFARIN SODIUM (2MG)ORALTABLETFalsePANWARFIN
119NDA017020_002discontinuedWARFARIN SODIUM (2.5MG)ORALTABLETFalsePANWARFIN
120NDA017020_003discontinuedWARFARIN SODIUM (5MG)ORALTABLETFalsePANWARFIN
121NDA017020_004discontinuedWARFARIN SODIUM (7.5MG)ORALTABLETFalsePANWARFIN
122NDA017020_005discontinuedWARFARIN SODIUM (10MG)ORALTABLETFalsePANWARFIN

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1c0f238ff-2804-4150-9766-22a5111b4e74 (view SPL)These highlights do not include all the information needed to use COUMADIN safely and effectively. See full prescribing information for COUMADIN. COUMADIN (warfarin sodium) tablets, for oral useCOUMADIN (warfarin sodium) for injection, for intravenous useInitial U.S. Approval: 1954prescriptionHuman PrescriptionBristol-Myers Squibb Holdings Pharma, Ltd. Liability Company2011-10-045005900324

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII