ANDA 207057

CSPC OUYI

FDA Drug Application

Application #207057

Application Sponsors

ANDA 207057

CSPC OUYI

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	600MG	0	GABAPENTIN	GABAPENTIN
002	TABLET;ORAL	800MG	0	GABAPENTIN	GABAPENTIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CSPC OUYI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207057
            [companyName] => CSPC OUYI
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-26
        )

)