Application Sponsors
| ANDA 202929 | MACLEODS PHARMS 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 | 2015-01-30 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-12-03 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-12-03 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2019-12-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 13 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202929
[companyName] => MACLEODS PHARMS 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":"01\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/03\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/03\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/03\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-12-03
)
)