ANDA 078493

DR REDDYS LABS LTD

FDA Drug Application

Application #078493

Documents

• Other Important Information from FDA: 2008-09-19

Application Sponsors

ANDA 078493

DR REDDYS LABS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	1MG	0	TRANDOLAPRIL	TRANDOLAPRIL
002	TABLET;ORAL	2MG	0	TRANDOLAPRIL	TRANDOLAPRIL
003	TABLET;ORAL	4MG	0	TRANDOLAPRIL	TRANDOLAPRIL

FDA Submissions

	ORIG	1	AP	2008-08-25
LABELING; Labeling	SUPPL	2	AP	2015-06-30
LABELING; Labeling	SUPPL	3	AP	2015-06-30	STANDARD

Submissions Property Types

SUPPL	2	Null	15
SUPPL	3	Null	7

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78493
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANDOLAPRIL","activeIngredients":"TRANDOLAPRIL","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANDOLAPRIL","activeIngredients":"TRANDOLAPRIL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANDOLAPRIL","activeIngredients":"TRANDOLAPRIL","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRANDOLAPRIL","submission":"TRANDOLAPRIL","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANDOLAPRIL","submission":"TRANDOLAPRIL","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANDOLAPRIL","submission":"TRANDOLAPRIL","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)