ANDA 091165

WOCKHARDT LTD

FDA Drug Application

Application #091165

Application Sponsors

ANDA 091165

WOCKHARDT LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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

ORIG

1

AP

2011-07-14

Submissions Property Types

ORIG

1

Null

7

CDER Filings

WOCKHARDT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91165
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESZOPICLONE","activeIngredients":"ESZOPICLONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ESZOPICLONE","activeIngredients":"ESZOPICLONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ESZOPICLONE","activeIngredients":"ESZOPICLONE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESZOPICLONE","submission":"ESZOPICLONE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ESZOPICLONE","submission":"ESZOPICLONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ESZOPICLONE","submission":"ESZOPICLONE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)