ANDA 203087

BRECKENRIDGE

FDA Drug Application

Application #203087

Application Sponsors

ANDA 203087

BRECKENRIDGE

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

UNKNOWN;

ORIG

1

AP

2019-05-08

Submissions Property Types

ORIG

1

Null

15

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203087
            [companyName] => NOSTRUM LABS INC
            [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":"05\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-08
        )

)