Application Sponsors
ANDA 083823 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | TABLET;ORAL | 500MG | 0 | NICOLAR | NIACIN |
FDA Submissions
| ORIG | 1 | AP | 1973-11-26 | |
LABELING; Labeling | SUPPL | 9 | AP | 1993-02-01 | |
LABELING; Labeling | SUPPL | 10 | AP | 1993-05-27 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 83823
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"NICOLAR","activeIngredients":"NIACIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NICOLAR","submission":"NIACIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)