ANDA 209872

STI PHARMA LLC

FDA Drug Application

Application #209872

Application Sponsors

ANDA 209872

STI PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	25MG	0	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE
002	CAPSULE;ORAL	50MG	0	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-05-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

STI PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209872
            [companyName] => STI PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-07
        )

)