ANDA 076045

SUN PHARM INDS LTD

FDA Drug Application

Application #076045

Documents

• Letter: 2003-04-15

Application Sponsors

ANDA 076045

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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	2001-08-29
LABELING; Labeling	SUPPL	7	AP	2009-06-29

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76045
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORAZEPAM","submission":"LORAZEPAM","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LORAZEPAM","submission":"LORAZEPAM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LORAZEPAM","submission":"LORAZEPAM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)