ANDA 076189

UPSHER SMITH LABS

FDA Drug Application

Application #076189

Documents

• Other Important Information from FDA: 2005-08-01

Application Sponsors

ANDA 076189

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	15MG	0	MIRTAZAPINE	MIRTAZAPINE
002	TABLET;ORAL	30MG	0	MIRTAZAPINE	MIRTAZAPINE
003	TABLET;ORAL	45MG	0	MIRTAZAPINE	MIRTAZAPINE

FDA Submissions

ORIG

1

AP

2003-06-19

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76189
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"45MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"45MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)