Documents
Application Sponsors
NDA 020156 | BRISTOL-MYERS SQUIBB | |
Marketing Status
Application Products
001 | FOR SOLUTION;ORAL | 10MG/ML | 1 | VIDEX | DIDANOSINE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1991-10-09 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 4 | AP | 1992-09-25 | |
LABELING; Labeling | SUPPL | 5 | AP | 1994-02-10 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 1995-08-21 | STANDARD |
EFFICACY; Efficacy | SUPPL | 7 | AP | 1994-08-05 | PRIORITY |
LABELING; Labeling | SUPPL | 8 | AP | 1995-08-21 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 1994-02-10 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 1995-08-21 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 1995-08-21 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 1996-06-26 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 1995-06-15 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-07-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1996-03-13 | |
EFFICACY; Efficacy | SUPPL | 16 | AP | 1996-07-17 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 1996-06-26 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 1998-04-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1998-06-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1998-03-05 | |
EFFICACY; Efficacy | SUPPL | 21 | AP | 1999-07-01 | STANDARD |
EFFICACY; Efficacy | SUPPL | 22 | AP | 1999-10-28 | PRIORITY |
LABELING; Labeling | SUPPL | 23 | AP | 2000-07-03 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2000-07-24 | STANDARD |
EFFICACY; Efficacy | SUPPL | 25 | AP | 2000-07-24 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2001-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 27 | AP | 2001-09-10 | STANDARD |
LABELING; Labeling | SUPPL | 28 | AP | 2001-11-16 | STANDARD |
EFFICACY; Efficacy | SUPPL | 29 | AP | 2002-04-01 | UNKNOWN |
LABELING; Labeling | SUPPL | 31 | AP | 2002-09-25 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2002-09-25 | STANDARD |
LABELING; Labeling | SUPPL | 33 | AP | 2003-03-04 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2004-01-21 | STANDARD |
LABELING; Labeling | SUPPL | 39 | AP | 2006-08-18 | STANDARD |
LABELING; Labeling | SUPPL | 40 | AP | 2006-11-29 | STANDARD |
LABELING; Labeling | SUPPL | 44 | AP | 2009-06-11 | STANDARD |
REMS; REMS | SUPPL | 46 | AP | 2010-01-25 | UNKNOWN |
REMS; REMS | SUPPL | 47 | AP | 2011-05-10 | N/A |
LABELING; Labeling | SUPPL | 48 | AP | 2011-11-18 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 51 | AP | 2014-08-08 | STANDARD |
LABELING; Labeling | SUPPL | 53 | AP | 2018-01-25 | STANDARD |
LABELING; Labeling | SUPPL | 54 | AP | 2018-12-17 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 11 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 29 | Null | 26 |
SUPPL | 46 | Null | 7 |
SUPPL | 47 | Null | 31 |
SUPPL | 48 | Null | 6 |
SUPPL | 51 | Null | 7 |
SUPPL | 53 | Null | 7 |
SUPPL | 54 | Null | 15 |
CDER Filings
BRISTOL-MYERS SQUIBB
cder:Array
(
[0] => Array
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[companyName] => BRISTOL-MYERS SQUIBB
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[originalApprovals] => [{"actionDate":"VIDEX","submission":"DIDANOSINE","actionType":"10MG\/ML","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-12-17
)
)