ANDA 078203

LEADING PHARMA LLC

FDA Drug Application

Application #078203

Application Sponsors

ANDA 078203

LEADING PHARMA LLC

Marketing Status

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

Application Products

001	TABLET;ORAL	0.5MG	0	LORAZEPAM	LORAZEPAM
002	TABLET;ORAL	1MG	0	LORAZEPAM	LORAZEPAM
003	TABLET;ORAL	2MG	0	LORAZEPAM	LORAZEPAM

FDA Submissions

ORIG

1

AP

2007-07-30

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

LEADING PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78203
            [companyName] => LEADING PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORAZEPAM","submission":"LORAZEPAM","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LORAZEPAM","submission":"LORAZEPAM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LORAZEPAM","submission":"LORAZEPAM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)