Application Sponsors
NDA 020055 | SANOFI AVENTIS US | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Application Products
001 | TABLET;ORAL | 1.5MG | 0 | GLYBURIDE (MICRONIZED) | GLYBURIDE |
002 | TABLET;ORAL | 3MG | 0 | GLYBURIDE (MICRONIZED) | GLYBURIDE |
003 | TABLET;ORAL | 6MG | 0 | GLYBURIDE (MICRONIZED) | GLYBURIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1992-04-17 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 1995-02-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-05-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-12-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-12-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-02-05 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-03-08 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 20055
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"GLYBURIDE (MICRONIZED)","activeIngredients":"GLYBURIDE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLYBURIDE (MICRONIZED)","activeIngredients":"GLYBURIDE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLYBURIDE (MICRONIZED)","activeIngredients":"GLYBURIDE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"GLYBURIDE (MICRONIZED)","submission":"GLYBURIDE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLYBURIDE (MICRONIZED)","submission":"GLYBURIDE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLYBURIDE (MICRONIZED)","submission":"GLYBURIDE","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)