ANDA 077198

ACTAVIS LABS FL INC

FDA Drug Application

Application #077198

Application Sponsors

ANDA 077198

ACTAVIS LABS FL INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	0.5MG	0	ALPRAZOLAM	ALPRAZOLAM
002	TABLET, EXTENDED RELEASE;ORAL	1MG	0	ALPRAZOLAM	ALPRAZOLAM
003	TABLET, EXTENDED RELEASE;ORAL	2MG	0	ALPRAZOLAM	ALPRAZOLAM
004	TABLET, EXTENDED RELEASE;ORAL	3MG	0	ALPRAZOLAM	ALPRAZOLAM

FDA Submissions

ORIG

1

AP

2010-05-13

Submissions Property Types

ORIG

1

Null

7

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77198
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"0.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"1MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"2MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"3MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"0.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"1MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"2MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"3MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)