Documents
Application Sponsors
| NDA 021178 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | GLUCOVANCE | GLYBURIDE; METFORMIN HYDROCHLORIDE |
| 002 | TABLET;ORAL | 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | GLUCOVANCE | GLYBURIDE; METFORMIN HYDROCHLORIDE |
| 003 | TABLET;ORAL | 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | GLUCOVANCE | GLYBURIDE; METFORMIN HYDROCHLORIDE |
FDA Submissions
| TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination | ORIG | 1 | AP | 2000-07-31 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2001-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-07-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2002-09-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2002-07-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2004-03-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2006-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2008-09-16 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2009-11-24 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2010-11-24 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2013-03-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2013-08-15 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2013-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2017-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2017-04-05 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 18 | AP | 2018-12-27 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 8 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 21178
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"GLUCOVANCE","activeIngredients":"GLYBURIDE; METFORMIN HYDROCHLORIDE","strength":"1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"GLUCOVANCE","activeIngredients":"GLYBURIDE; METFORMIN HYDROCHLORIDE","strength":"2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"GLUCOVANCE","activeIngredients":"GLYBURIDE; METFORMIN HYDROCHLORIDE","strength":"5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/27\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021178s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021178s016s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021178s016s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021178s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021178s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2010","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021178s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2009","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021178s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2008","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021178s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2006","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021178s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2004","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21178se5-007_glucovance_lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2002","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21178s4lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21178lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"GLUCOVANCE","submission":"GLYBURIDE; METFORMIN HYDROCHLORIDE","actionType":"1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"GLUCOVANCE","submission":"GLYBURIDE; METFORMIN HYDROCHLORIDE","actionType":"2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"GLUCOVANCE","submission":"GLYBURIDE; METFORMIN HYDROCHLORIDE","actionType":"5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-12-27
)
)