Application Sponsors
| ANDA 208451 | AUROBINDO PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 1MG | 0 | ESZOPICLONE | ESZOPICLONE |
| 002 | TABLET;ORAL | 2MG | 0 | ESZOPICLONE | ESZOPICLONE |
| 003 | TABLET;ORAL | 3MG | 0 | ESZOPICLONE | ESZOPICLONE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-09-15 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-11-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 208451
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ESZOPICLONE","activeIngredients":"ESZOPICLONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESZOPICLONE","activeIngredients":"ESZOPICLONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESZOPICLONE","activeIngredients":"ESZOPICLONE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/04\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/04\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-04
)
)