ANDA 091378

APOTEX CORP

FDA Drug Application

Application #091378

Application Sponsors

ANDA 091378

APOTEX CORP

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

ORIG

1

TA

2011-04-25

Submissions Property Types

ORIG

1

Null

42

CDER Filings

APOTEX CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91378
            [companyName] => APOTEX CORP
            [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":"SILDENAFIL CITRATE","submission":"SILDENAFIL CITRATE","actionType":"25MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"SILDENAFIL CITRATE","submission":"SILDENAFIL CITRATE","actionType":"50MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"SILDENAFIL CITRATE","submission":"SILDENAFIL CITRATE","actionType":"100MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)