Application Sponsors
ANDA 088826 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 250MG | 0 | CHLORPROPAMIDE | CHLORPROPAMIDE |
FDA Submissions
| ORIG | 1 | AP | 1984-09-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-10-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1987-04-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1988-04-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1988-04-25 | |
LABELING; Labeling | SUPPL | 8 | AP | 1988-06-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1990-06-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1991-05-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1991-01-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1991-06-13 | |
LABELING; Labeling | SUPPL | 13 | AP | 1991-11-27 | |
LABELING; Labeling | SUPPL | 14 | AP | 1991-12-26 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
CDER Filings
ANI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 88826
[companyName] => ANI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORPROPAMIDE","activeIngredients":"CHLORPROPAMIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLORPROPAMIDE","submission":"CHLORPROPAMIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)