Application Sponsors
ANDA 089446 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 100MG | 0 | CHLORPROPAMIDE | CHLORPROPAMIDE |
FDA Submissions
| ORIG | 1 | AP | 1986-11-17 | |
LABELING; Labeling | SUPPL | 5 | AP | 1988-03-28 | |
LABELING; Labeling | SUPPL | 6 | AP | 1989-05-17 | |
LABELING; Labeling | SUPPL | 8 | AP | 1991-07-30 | |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 89446
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORPROPAMIDE","activeIngredients":"CHLORPROPAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLORPROPAMIDE","submission":"CHLORPROPAMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)