Documents
Application Sponsors
| NDA 009218 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Prescription | 005 |
| Prescription | 007 |
| Discontinued | 012 |
| Prescription | 013 |
| Prescription | 016 |
| Prescription | 018 |
| Discontinued | 020 |
| Prescription | 022 |
| Prescription | 023 |
| Discontinued | 024 |
| Prescription | 025 |
| Prescription | 026 |
Application Products
| 005 | TABLET;ORAL | 10MG | 1 | COUMADIN | WARFARIN SODIUM |
| 007 | TABLET;ORAL | 5MG | 1 | COUMADIN | WARFARIN SODIUM |
| 012 | INJECTABLE;INJECTION | 75MG/VIAL | 0 | COUMADIN | WARFARIN SODIUM |
| 013 | TABLET;ORAL | 2MG | 1 | COUMADIN | WARFARIN SODIUM |
| 016 | TABLET;ORAL | 7.5MG | 1 | COUMADIN | WARFARIN SODIUM |
| 018 | TABLET;ORAL | 2.5MG | 1 | COUMADIN | WARFARIN SODIUM |
| 020 | INJECTABLE;INJECTION | 50MG/VIAL | 0 | COUMADIN | WARFARIN SODIUM |
| 022 | TABLET;ORAL | 1MG | 1 | COUMADIN | WARFARIN SODIUM |
| 023 | TABLET;ORAL | 4MG | 1 | COUMADIN | WARFARIN SODIUM |
| 024 | INJECTABLE;INJECTION | 5MG/VIAL | 0 | COUMADIN | WARFARIN SODIUM |
| 025 | TABLET;ORAL | 3MG | 1 | COUMADIN | WARFARIN SODIUM |
| 026 | TABLET;ORAL | 6MG | 1 | COUMADIN | WARFARIN SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1954-06-08 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 1975-08-21 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1976-09-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1977-02-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1977-12-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1978-04-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1979-07-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1980-04-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1980-02-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1980-12-29 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 1987-07-06 | |
| LABELING; Labeling | SUPPL | 52 | AP | 1985-01-17 | |
| LABELING; Labeling | SUPPL | 54 | AP | 1985-02-25 | |
| LABELING; Labeling | SUPPL | 56 | AP | 1985-05-13 | |
| LABELING; Labeling | SUPPL | 59 | AP | 1986-07-08 | |
| LABELING; Labeling | SUPPL | 60 | AP | 1987-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 1988-07-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1990-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 1990-03-01 | |
| LABELING; Labeling | SUPPL | 64 | AP | 1990-03-01 | |
| LABELING; Labeling | SUPPL | 65 | AP | 1990-04-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 1991-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 1991-04-11 | |
| LABELING; Labeling | SUPPL | 68 | AP | 1991-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 1993-12-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 1993-08-24 | STANDARD |
| LABELING; Labeling | SUPPL | 71 | AP | 1992-08-20 | |
| LABELING; Labeling | SUPPL | 72 | AP | 1993-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 73 | AP | 1993-06-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 74 | AP | 1994-03-31 | PRIORITY |
| LABELING; Labeling | SUPPL | 75 | AP | 1993-08-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 76 | AP | 1995-04-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 77 | AP | 1995-02-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 78 | AP | 1995-02-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 79 | AP | 1995-03-08 | STANDARD |
| LABELING; Labeling | SUPPL | 80 | AP | 1995-09-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 83 | AP | 1996-11-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 84 | AP | 1996-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 85 | AP | 1996-09-05 | STANDARD |
| LABELING; Labeling | SUPPL | 86 | AP | 1998-06-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 87 | AP | 1998-11-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 88 | AP | 1997-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 89 | AP | 1998-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 90 | AP | 1998-06-01 | STANDARD |
| LABELING; Labeling | SUPPL | 91 | AP | 1998-06-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 93 | AP | 1998-12-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 94 | AP | 1999-03-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 95 | AP | 1999-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 96 | AP | 1999-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 97 | AP | 2000-02-17 | STANDARD |
| LABELING; Labeling | SUPPL | 98 | AP | 2002-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 99 | AP | 2002-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 101 | AP | 2005-09-02 | STANDARD |
| LABELING; Labeling | SUPPL | 102 | AP | 2006-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 105 | AP | 2007-08-16 | STANDARD |
| LABELING; Labeling | SUPPL | 107 | AP | 2011-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 108 | AP | 2010-01-22 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 113 | AP | 2013-03-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 114 | AP | 2014-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 115 | AP | 2015-10-28 | STANDARD |
| LABELING; Labeling | SUPPL | 116 | AP | 2016-09-08 | STANDARD |
| LABELING; Labeling | SUPPL | 117 | AP | 2017-05-22 | STANDARD |
| LABELING; Labeling | SUPPL | 118 | AP | 2017-08-14 | STANDARD |
Submissions Property Types
| SUPPL | 33 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 70 | Null | 0 |
| SUPPL | 77 | Null | 0 |
| SUPPL | 78 | Null | 0 |
| SUPPL | 79 | Null | 0 |
| SUPPL | 83 | Null | 0 |
| SUPPL | 84 | Null | 0 |
| SUPPL | 87 | Null | 0 |
| SUPPL | 88 | Null | 0 |
| SUPPL | 89 | Null | 0 |
| SUPPL | 93 | Null | 0 |
| SUPPL | 94 | Null | 0 |
| SUPPL | 95 | Null | 0 |
| SUPPL | 107 | Null | 7 |
| SUPPL | 108 | Null | 7 |
| SUPPL | 113 | Null | 0 |
| SUPPL | 114 | Null | 0 |
| SUPPL | 115 | Null | 15 |
| SUPPL | 116 | Null | 6 |
| SUPPL | 117 | Null | 6 |
| SUPPL | 118 | Null | 7 |
TE Codes
| 005 | Prescription | AB |
| 007 | Prescription | AB |
| 013 | Prescription | AB |
| 016 | Prescription | AB |
| 018 | Prescription | AB |
| 022 | Prescription | AB |
| 023 | Prescription | AB |
| 025 | Prescription | AB |
| 026 | Prescription | AB |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 9218
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/009218s118lbl.pdf#page=30"]
[products] => [{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"75MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"COUMADIN","activeIngredients":"WARFARIN SODIUM","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/14\/2017","submission":"SUPPL-118","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/009218s118lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2017","submission":"SUPPL-118","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/009218s118lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2017","submission":"SUPPL-117","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/009218s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2017","submission":"SUPPL-117","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/009218s017lbl.pdf\"}]","notes":""},{"actionDate":"09\/08\/2016","submission":"SUPPL-116","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/009218s116lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2015","submission":"SUPPL-115","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/009218s115lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2015","submission":"SUPPL-115","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/009218s115lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2011","submission":"SUPPL-107","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/009218s107lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2010","submission":"SUPPL-108","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/009218s108lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2007","submission":"SUPPL-105","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/009218s105lblv2.pdf\"}]","notes":""},{"actionDate":"10\/04\/2006","submission":"SUPPL-102","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/009218s102lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2005","submission":"SUPPL-101","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/009218s101lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"75MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"5MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"COUMADIN","submission":"WARFARIN SODIUM","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-08-14
)
)