Application Sponsors
| ANDA 072112 | AUROLIFE PHARMA LLC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | CAPSULE;ORAL | 15MG | 0 | CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM |
| 002 | CAPSULE;ORAL | 3.75MG | 0 | CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM |
| 003 | CAPSULE;ORAL | 7.5MG | 0 | CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM |
FDA Submissions
| ORIG | 1 | AP | 1988-08-26 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1999-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-03-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-03-09 | |
| LABELING; Labeling | SUPPL | 10 | AP | 2016-12-16 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 10 | Null | 15 |
CDER Filings
AUROLIFE PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 72112
[companyName] => AUROLIFE PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"CLORAZEPATE DIPOTASSIUM","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLORAZEPATE DIPOTASSIUM","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"3.75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLORAZEPATE DIPOTASSIUM","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"7.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CLORAZEPATE DIPOTASSIUM","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLORAZEPATE DIPOTASSIUM","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"3.75MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLORAZEPATE DIPOTASSIUM","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"7.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)