Application Sponsors
| ANDA 070886 | AUROLIFE PHARMA LLC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 0.2MG | 0 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 0.1MG | 0 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 0.3MG | 0 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1988-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1992-03-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-02-01 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1998-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-03-02 | |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 70886
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)