ANDA 202597

DR REDDYS LABS LTD

FDA Drug Application

Application #202597

Application Sponsors

ANDA 202597

DR REDDYS LABS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	TABLET; ORAL	25MG	0	SILDENAFIL CITRATE	SILDENAFIL CITRATE
002	TABLET; ORAL	50MG	0	SILDENAFIL CITRATE	SILDENAFIL CITRATE
003	TABLET; ORAL	100MG	0	SILDENAFIL CITRATE	SILDENAFIL CITRATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2012-09-26

Submissions Property Types

ORIG

1

Null

42

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202597
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"25MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"50MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"100MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/26\/2012","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-09-26
        )

)