ANDA 078387

AMNEAL PHARMS NY

FDA Drug Application

Application #078387

Application Sponsors

ANDA 078387

AMNEAL PHARMS NY

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 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

2008-05-30

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78387
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"0.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"1MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"2MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"3MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"0.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"1MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"2MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"3MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)